{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 101 } }, "results": [ { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps" ], "spl_product_data_elements": [ "Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Temporary Relief of Occasional Constipation Compare to the Active Ingredient of Ducolax®* Gentle Laxative Bisacodyl Stimulant Laxative 25 Tablets 5 mg each TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF00000 50844 REV0510B32765 Our Family 44-327-56 Product Label" ], "indications_and_usage": [ "Use(s) relieves occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "050780d6-b1bd-4717-b517-527b86bb9dfa", "id": "aa329d94-d60c-4a9b-aebd-d707ba6bedb1", "active_ingredient": [ "Active ingredient Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20130320", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Allergy alert: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Stomach bleeding warning: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? (800) 616-2471" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;291" ], "ask_doctor": [ "Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "storage_and_handling": [ "Other information store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package" ], "do_not_use": [ "Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "IBUPROFEN TABLET, FILM COATED Label Image" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "090fccce-3bcf-4541-afce-8577a9838b23", "id": "a4a288bd-5325-40f0-a03f-abb9b68b609c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive ingredients carnauba wax, cellulose, crospovidone, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica gel, sodium starch glycolate, starch, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain reliever Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if glaucoma liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis high blood pressure diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability occurs, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage excitability occurs, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Maximum Strength Allergy Sinus Acetaminophen, Chlorpheniramine maleate, Pseudoephedrine HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CARNAUBA WAX CROSPOVIDONE FD&C YELLOW NO. 6 MAGNESIUM STEARATE TITANIUM DIOXIDE 44;342" ], "ask_doctor": [ "Ask a doctor before use if glaucoma liver disease heart disease thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis high blood pressure diabetes" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over: 2 caplets every 4 to 6 hours. Do not take more than 8 caplets in 24 hours. children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number for better identification keep caplets in carton until used" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal display panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDEDǂ NDC 0363-0342-08 MAXIMUM STRENGTH Allergy Sinus-D D Allergy & Sinus Acetaminophen 500 mg / Pain Reliever Pseudoephedrine HCl 30 mg / Nasal Decongestant Chlorpheniramine Maleate 2 mg / Antihistamine • Relief of runny nose, sneezing, nasal congestion, sinus pain/pressure & itchy, watery eyes 24 CAPLETS ǂWalgreens Pharmacist Survey Study, November 2010. 50844 ORG101115712 ITEM 510072 ORG1112-F DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Walgreens 44-342 Walgreens 44-342" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sinus pain headache sinus pressure runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "0a4ace8c-562e-43af-9efb-d323ee4c22ab", "id": "8ea5f196-8c1b-43ba-98c0-b23e18ee3ebc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Chlorpheniramine maleate 2 mg Pseudoephedrine HCl 30 mg" ] }, { "effective_time": "20110111", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Purpose: Antihistimine", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warnings Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are: taking any drugs for asthma taking sedatives or tranquilizers", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "When using this product Drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitaility may occur, especially in children", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE DIPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 STARCH, CORN PINK WHITE CPC;835 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: do not give to children under 12 years of age unless directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967", "Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "DIPHEN_PDP", "DIPHEN_PANEL", "ONEPERSONKIT_FRONT", "ONEPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever", "Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes" ], "set_id": "0adedf0d-6c71-4ed9-963f-1fc41c1ae0f6", "id": "22f141f4-f307-4e18-a8ca-275e075f2547", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient (in each tablet) Purpose Diphenhydramine Hydrochloride 25mg............................... Antihistimine", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20151006", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION Carbopol 934p, Di-calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, D&C Red # 27, FD&C Blue # 2, FD&C Red # 40, Hypromellose, Macrogol, Polydextrose, Talc, Titanium Dioxide, Triacetin." ], "package_label_principal_display_panel": [ "ACKAGE LABEL PRINCIPAL DISPLAY PANEL Uralgic label" ], "spl_product_data_elements": [ "Uralgic Methenamine, Sodium Biphosphate, Phenyl Salicylate, Methylene Blue, Hyoscyamine HYOSCYAMINE SULFATE HYOSCYAMINE POLYDEXTROSE TITANIUM DIOXIDE TALC D&C RED NO. 27 TRIACETIN CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 FD&C RED NO. 40 HYPROMELLOSES POLYETHYLENE GLYCOLS CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) METHENAMINE METHENAMINE METHYLENE BLUE METHYLENE BLUE CATION PHENYL SALICYLATE PHENYL SALICYLATE POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM CATION WP;103" ], "description": [ "DESCRIPTION SECTION Each tablet contains: Methenamine, USP ------------------------- 81.6 mg Sodium Biphosphate, USP –------------- 40.8 mg Phenyl Salicylate, USP --------------------- 36.2 mg Methylene Blue, USP ----------------------- 10.8 mg Hyoscyamine Sulfate, USP ---------------- 0.12 mg" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY SECTION HYOSCYAMINE is a parasympatholytic which relaxes smooth muscles and thus produces an antispasmodic effect. It is well absorbed from the gastrointestinal tract and is rapidly distributed throughout body tissues. Most is excreted in the urine within 12 hours, 13% to 50% being unchanged. Its biotransformation is hepatic. Its protein binding is moderate. PHENYL SALICYLATE releases salicylate, a mild analgesic for pain. METHENAMINE degrades in an acidic urine environment releasing formaldehyde which provides bactericidal or bacteriostatic action. It is well absorbed from the gastrointestinal tract. 70% to 90% reaches the urine unchanged at which point it is hydrolyzed if the urine is acidic. Within 24 hours it is almost completely (90%) excreted; of this amount at pH 5, approximately 20% is formaldehyde. Protein binding: some formaldehyde is bound to substances in the urine and surrounding tissues. Methenamine is freely distributed to body tissues and fluids but is not clinically significant as it does not hydrolyze at pH greater than 6.8. METHYLENE BLUE possesses weak antiseptic properties. It is well absorbed in the gastrointestinal tract and is rapidly reduced to leukomethylene blue which is stabilized in some combination form in the urine. 75% is excreted unchanged. MONOBASIC SODIUM PHOSPHATE helps to maintain an acid pH in the urine necessary for the degradation of methenamine." ], "set_id": "0b758028-9c9c-50c6-e054-00144ff88e88", "id": "21753fae-69d5-4c23-e054-00144ff88e88", "openfda": {}, "version": "5" }, { "effective_time": "20101208", "inactive_ingredient": [ "INACTIVE INGREDIENT carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "OTC - PURPOSE ain reliever/fever reducer" ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ● hives ● facial swelling ● asthma (wheezing) ● shock ● skin reddening ● rash ● blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing perscription or nonperscription NSAIDs [aspirin, ibuprofen, naproxen, or others] ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed" ], "pregnancy": [ "IF PREGNANT OR BREAST FEEDING ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "when_using": [ "OTC - WHEN USING ● temporarily relieves minor aches and pains due to: ● headache ● toothache ● backache ● menstrual cramps ● the common cold ● muscular aches ● minor pain of arthritis ● temporarily reduces fever", "OTC - WHEN USING take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see WARNINGS ) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist ● if pain or fever does not respond to 1 tablet, 2 tablets may be used ● do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "spl_product_data_elements": [ "IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN CARNAUBA WAX STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE TABLET IP;143" ], "ask_doctor": [ "OTC - ASK DOCTOR stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic", "STOP USE AND ASK DOCTOR IF you experience any of the following signs of stomach bleeding:. ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "openfda": {}, "version": "135", "spl_unclassified_section": [ "KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "OTC - DO NOT USE ● if you have ever had an allergic reaction to any other pain reliever/fever reducer ● right before or after heart surgery" ], "information_for_patients": [ "OTHER INFORMATION ● store at controlled room temperature ● avoid excessive heat above 40(104 ● use by expiration date on package" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 49349-123-02 STRENGTH:200 mg COLOR: orange SHAPE: ROUND SCORE: No score SIZE: 13 mm IMPRINT: IP;143 QTY: 30 MM1 MM2" ], "set_id": "0f6f9f60-f5ae-47dc-9fda-bae44b4a2d8e", "id": "fe0570c8-aba5-4bb6-8fc5-74a341704091", "ask_doctor_or_pharmacist": [ "OTC - ASK DOCTOR/PHARMACIST under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151009", "inactive_ingredient": [ "Inactive ingredients black iron oxide, cellulose, colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye\"s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Enteric Aspirin Aspirin ASPIRIN ASPIRIN FERROSOFERRIC OXIDE SILICON DIOXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BICARBONATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;227" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store in a cool dry place at controlled room temperature 15°-30°C (59°-86°F) use by expiration date on package" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68198-227-14 pain reliever SIMPLY RIGHT ™ regular strength enteric coated aspirin aspirin tablets, 325 mg pain reliever (NSAID) Compare to Ecotrin® active ingredient safety coated aspirin regimen actual size 500 t ablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 ORG011022714 Distributed by: SAM’S West, Inc., Bentonville, AR 72716 227-14 227-14" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains due to: headache muscle pain toothache menstrual pain the common cold minor pain of arthritis" ], "set_id": "103dab40-9c26-49ee-b984-b96e95d4f588", "id": "d24cc976-0ce0-4768-8c69-ccbf64ef2f36", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-356-0783" ], "spl_product_data_elements": [ "Rapid Comfort Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 Rapid Comfort Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Label Safety Ibuprofen Label 60683-083 Lab Safety Ibuprofen Label 60683-083 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-083", "Lab Safety Ibuprofen Label 60683-082 Lab Safety Ibuprofen Label 60683-082 Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Facil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias rap04-0000-01-2 Lab Safety Label 60683-082" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "108f8ac2-7b89-422d-9bb2-d26c4e01e939", "id": "0c3b148b-f2b9-3a0e-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141114", "inactive_ingredient": [ "Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "MEDIQUE I-PRIN Ibuprofen SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 MEDI-FIRST PLUS Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Dover Addaprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Otis Clapp Ultraprin Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Physicians Care Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140 Lab Safety Supply Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug Purpose Pain reliever/fever reducer Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever. Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain Questions or comments? 1-800-634-7680" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Medique® I-Prin Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 24 tablets (12 x 2) Compare active ingredient to Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 100 tablets (50 x 2) Compare active ingredient to: Genuine Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Medi-First® Plus Ibuprofen 200 mg See new warnings information Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets 250 tablets (125 x 2) Compare active ingredient to: Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets Rapid Comfort SM Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film Coated Tablets Compare active ingredient to: Advil® Registered trademark of Whitehall-Robins See new warnings information 100 Tablets (50 x 2s) Tamper Evident Unit Dose Packets Dover Addaprin Pain Reliever-Fever Reducer Ibuprofen 200 MG. Tablets (NSAID) See new warnings information Dover Pharmaceutical Products of the highest quality and effectiveness Tamper Resistant Sealed Packets Unit Dose Packs 500 Tablets (250 Packets of 2) OC Otis Clapp Quality & Integrity Since 1840 Ultraprin ™ Pain Reliever-Fever Reducer (NSAID) Ibuprofen Tablets USP 200 mg For Deep Seated Pain See Warnings and directions on Side Panel See new warnings information Tear out along perforation to dispense Professional Healthcare 300 Tablets (150 Packets of 2) Physician's Care® Ibuprofen Anti-inflammatory, Fever Reducer & Pain Reliever (NSAID) Coated Tablets Compare active ingredient to: Advil® Registered trademark of Wyeth Corporation Tamper Evident Packets of 2 tablets See new warnings information Physicians Care® Registered trademark of Acme United Corporation 50 Packets (2 Tablets 200 mg Each) Medique Iprin Medi-First Ibuprofen Medi0First Plus Ibuprofen Lab Safety Ibuprofen Dover Addaprin Otis Clapp Ultraprin Physicians Care" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever." ], "set_id": "130baa8b-c8a0-4d72-94c9-6eb8dc8c7c29", "id": "07d899a0-08bc-57b3-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20130924", "inactive_ingredient": [ "Inactive Ingredients carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide." ], "purpose": [ "Purpose Acid reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers. Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days Pregnancy/Breastfeeding If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or Comments? Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) Consumer Information What you should know about MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg / Acid Reducer (Please read all this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference) What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide. What symptoms do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg treat and prevent? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieves and prevents heartburn associated with acid indigestion and sour stomach. Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort. Excellent Safety Record The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications. MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free. How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? To relieve symptoms, swallow 1 tablet with a glass of water. To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours). MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor. How do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduces the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid. Tips for managing heartburn Do not lie flat or bend over soon after eating Do not eat late at night, or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose fitting clothing around your stomach Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers When should I see a doctor? Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast feeding , ask a health professional before use. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away. Questions or Comments? Call 1-800-706-5575 (Monday to Friday, 8:30 am – 5:00 pm Eastern Standard Time) Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, FL Canada M9L 1T9 33326 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 ran-150mg-otc-esophagus" ], "spl_product_data_elements": [ "Ranitidine Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE RANITIDINE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE TITANIUM DIOXIDE VANILLIN FERRIC OXIDE RED FERRIC OXIDE YELLOW" ], "ask_doctor": [ "Ask a doctor before use if you have nausea or vomiting stomach pain unexplained weight loss frequent chest pain frequent wheezing, particularly with heartburn had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and Children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) do not chew tablet children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "Pregnancy/Breastfeeding If pregnant or breastfeeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days" ], "spl_unclassified_section": [ "Other Information do not use if bottle seal is open or torn store at 20° to 25°C (68° to 77°F) protect from light this product is sodium and sugar free" ], "do_not_use": [ "Do not use with other acid reducers if you have kidney disease, except under the advice and supervision of a doctor if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel OTC Medicine Maximum Strength Rantidine Tablets USP, 150 mg IMAGE LABEL" ], "indications_and_usage": [ "Use(s) Relieves heartburn associated with acid indigestion and sour stomach Prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages" ], "set_id": "14710d5d-16e8-48f8-9fd5-1530a087eb34", "id": "96b79fbb-56cb-4338-8c37-3150d381782e", "active_ingredient": [ "Active Ingredient(s) Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)" ] }, { "effective_time": "20150501", "inactive_ingredient": [ "Inactive Ingredients Carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery" ], "questions": [ "Questions Questions or comments? Call Toll Free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm CST" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS STARCH, CORN FERRIC OXIDE RED SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE IBU200" ], "ask_doctor": [ "Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease • you have asthma • you are taking a diuretic Ask a doctor or pharmacist before use if • under a doctor's care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor • children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear" ], "storage_and_handling": [ "Other Information • store at 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "Principal Display Panel Medline NDC 53329-677-30 +Compare to the active ingredient in Advil Tablets Ibuprofen Tablets USP Pain Reliever/ Fever Reducer (NSAID) 200 mg 100 coated tablets - 200 mg each Ibuprofen Tablets PDP and drug facts" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: • headache • minor pain of arthritis • backache • menstrual cramps • muscular aches • toothache • the common cold • temporarily reduces fever" ], "set_id": "15821573-03c8-490f-9295-74430aa07dfe", "id": "15821573-03c8-490f-9295-74430aa07dfe", "active_ingredient": [ "Active ingredient Ibuprofen USP, 200 mg (NSAID)* ---------------------------------------------------- *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20101229", "inactive_ingredient": [ "Other Ingredients Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcelluslose, Dicalcium Phosphate, dI-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflaving. Contains Soy. May contain Povidone and Polydextrose. Contains No artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk based by-products." ], "contraindications": [ "CONTRAINDICATIONS Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately." ], "precautions": [ "PRECAUTIONS Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "warnings": [ "WARNINGS Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins." ], "spl_product_data_elements": [ "Multi-Nate 30 beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION CAPRYLIC/CAPRIC MONO/DIGLYCERIDES CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE MALTODEXTRIN STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE ACACIA SODIUM ALGINATE POLYETHYLENE GLYCOL SUCROSE STARCH, CORN HYDROGENATED SOYBEAN OIL HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE ALPHA-TOCOPHEROL, DL- TITANIUM DIOXIDE TRIACETIN POLYSORBATE 20 RIBOFLAVIN RE;316" ], "openfda": {}, "version": "11", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one tablet by mouth daily, or as directed by a physician." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088." ], "how_supplied": [ "HOW SUPPLIED Multi-Nate 30 is available as a dark pink tablet imprinted “RE 316”: bottles of 100 tablets NDC 68032-444-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store a controlled room temperature 15-30C (59-86F). Keep in a cool, dry place. WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only" ], "package_label_principal_display_panel": [ "PACKAGING label" ], "indications_and_usage": [ "INDICATIONS AND USAGE Multi-Nate 30 is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception. Multi-Nate 30: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid." ], "set_id": "195435f6-3c9b-4ac5-9502-859ef03c7523", "id": "7164daaf-b77f-4bff-bb44-8b7623cf52c2" }, { "effective_time": "20120224", "inactive_ingredient": [ "Inactive Ingredients Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide." ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems high blood pressure heart or kidney disease taken a diuretic reached age 60 or older Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs long term continuous use ay increase the risk of heart attack or stroke Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IP;140" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Dosage & Administration do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in a 24-hour period Children under 12 years ask a doctor Other information store at 20 – 25°C (68 – 77°F). Read all warnings and directions before use Questions or Comments? Call 1-877-835-5472 Monday though Friday 9AM – 5PM EST." ], "spl_unclassified_section": [ "*Compared to the active ingredient of Advil ® Drug Facts", "Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141", "*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil ® Rev. 10-2008" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Ibuprofen Tabs, USP 200mg Principal Display Panel-Ibuprofen Tablets, USP 200mg" ], "indications_and_usage": [ "Indications & Usage temporarily relieves minor aches and pains due to: headache muscular aches minor pain or arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "1b2ab0e2-ed21-4df8-bed2-55728a505c7d", "id": "915618ec-ed9f-4094-a144-dfae11a60690", "active_ingredient": [ "ACTIVE INGREDIENT (in each Tablet) Ibuprofen 200 mg (NSAID)** **nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in a 24-hour period
Children under 12 years ask a doctor
" ] }, { "effective_time": "20140710", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C Red # 27 aluminum lake, FD&C Blue # 2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Use for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing" ], "when_using": [ "When using this product do not chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk" ], "questions": [ "Questions? Call toll-free 1-888-285-9159 (English/Spanish) Or visit www.DULCOLAX.com" ], "spl_product_data_elements": [ "Dulcolax bisacodyl bisacodyl bisacodyl acacia ammonia calcium carbonate carnauba wax starch, corn D&C Red NO. 27 aluminum oxide FD&C Blue NO. 2 FD&C Yellow NO. 6 hypromelloses ferrosoferric oxide lactose magnesium stearate methylparaben polydextrose polyethylene glycols polyvinyl acetate phthalate povidone propylene glycol propylparaben shellac silicon dioxide sodium alginate sodium benzoate sodium bicarbonate stearic acid sucrose talc titanium dioxide triacetin triethyl citrate Round DW" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "storage_and_handling": [ "Other information store at controlled room temperature 15°-30°C (59°- 86°F) avoid excessive humidity" ], "active_ingredient_table": [ "
Drug Facts
Active ingredient (in each tablet) Purpose
Bisacodyl USP 5 mg ................................................................................. Stimulant laxative
" ], "package_label_principal_display_panel": [ "Dulcolax For Women Bisacodyl 5mg NDC: 0597-0150-26 Dulcolax for Women Carton" ], "indications_and_usage": [ "" ], "set_id": "1cf7ab57-2a41-ee23-c2a7-c53551da9643", "id": "4628d050-4931-3c01-7037-c25aa9a0e95d", "active_ingredient": [ "Drug Facts Active ingredient (in each tablet) Purpose Bisacodyl USP 5 mg ................................................................................. Stimulant laxative" ], "dosage_and_administration_table": [ "
take with a glass of water
adults and children 12 years and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20141222", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid, talc*, titanium dioxide, triglycerides* *contains one or more of these ingredients" ], "purpose": [ "Purpose Stool softener Stimulant laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call toll free 1-877-932-7948" ], "spl_product_data_elements": [ "Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides DOCUSATE SODIUM DOCUSATE SENNOSIDES SENNOSIDES CARNAUBA WAX CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED WATER SODIUM BENZOATE STEARIC ACID TITANIUM DIOXIDE C10-18 TRIGLYCERIDES SILICON DIOXIDE ALUMINUM OXIDE TCL097;SS2;S44" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablet contains: calcium 20 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 15º-30ºC (59º-86ºF), protect from excessive moisture" ], "do_not_use": [ "Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil, unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel COMPARE TO PERI-COLACE® ACTIVE INGREDIENTS† Stool Softener Plus Stimulant Laxative Docusate Sodium 50 mg/ Sennosides 8.6 mg For Overnight Relief of Occasional Constipation Effective, Reliable, Comfortable Tablets †This product is not manufactured or distributed Purdue Products L.P., owner of the registered trademark Peri-Colace® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA Contact us at 1-877-932-7948 or www.supervalu-ourownbrands.com", "Product Label Stool softener plus stimulant laxative Equaline" ], "indications_and_usage": [ "Uses for overnight relief from occasional constipation (irregularity) generally produces a bowel movement in 6 to 12 hours" ], "set_id": "21f8ea1e-38fe-4c93-854e-6cff16a0f2d3", "id": "6c5cfe49-5cc8-4800-acb9-5105ec0d941a", "active_ingredient": [ "Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1-2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 2 ask a doctor
" ] }, { "effective_time": "20110818", "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Purpose Analgesic/antipyretic", "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "description": [ "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other information: Store at room temperature.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59-86 degree F (15-30 degree C)", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)" ], "indications_and_usage": [ "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Use For preparation of skin before injection." ], "set_id": "2590aace-08b7-4727-b85c-82b1785ffbad", "id": "a514e24f-246f-4eae-98fc-71a80c66df04", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient (in each tablet) Acetaminophen 325 mg", "Active Ingredient Active Ingredient: Isopropyl Alcohol, 70% v/v" ], "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredient: Purified water", "Inactive Ingredients Cornstarch, polyethylene glycol, stearic acid, povidone", "Inactive Ingredient Purified water." ], "warnings": [ "Warnings: For external use only.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warning: For external use only.", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings For external use only." ], "spl_product_data_elements": [ "GFA First Aid Kit Essentials - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE White AZ;234 Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions Wipe Injection site vigorously and discard." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor." ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20140301" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use in the eyes or over large areas of the body.", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: with electrocautery, in the eyes." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID 100 Alcohol cleansing pads Reorder GFAP-39-02", "AntisepticTowelette", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "Alcohol Cleansing Pad", "Non Aspirin", "GFA Essentials" ] }, { "effective_time": "20101110", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-2 PERSON NATIONAL SKI PATROL FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "ONEPERSONKIT_FRONT", "ONEPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever" ], "set_id": "2c71e8b3-6117-4817-988f-2be3b1933887", "id": "c6534a3b-0e77-4a7c-8c8c-1068cfa3f130", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain Reliever Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days pain gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "spl_product_data_elements": [ "Allergy Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;518" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 to 6 hours do not take more than 8 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days pain gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel FRED'S ® Severe Allergy Pain Reliever/Antihistamine Sinus Pain - Acetaminophen Itchy, Watery Eyes Runny Nose Sneezing - Diphenhyrdamine HCl Pseudoephedrine Free 24 Coated Caplets Compare to the active ingredients in: Tylenol® Severe Allergy* TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Severe Allergy. 50844 REV0612D51808 Fred's 44-518 Fred's 44-518" ], "indications_and_usage": [ "Uses temporarily relieves: runny nose sneezing itching of the nose or throat and itchy, watery eyes due to hay fever headache minor aches and pains" ], "set_id": "2e51c2ef-80d3-4ad0-9ab6-5f70e8d48d67", "id": "aec2eb49-29dc-4efa-be4a-29e1c83cba2e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20091023", "inactive_ingredient": [ "Inactive Ingredients Fractionated coconut oil, Hypromellose, Maltodextrin, Microcrystalline cellulose, Polydextrose, Sodium starch glycolate, Stearic acid, Talc, Titanium dioxide." ], "purpose": [ "Uses for the temporary relief of minor aches and pain associated with: Tension Headaches Sinus Headaches Stress Headaches Chronic Headaches Menstrual Headaches" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include hives, asthma (wheezing), facial swelling, shock, rash, skin reddening, and blisters. Alcohol warning : If you consume 3 or more alcoholic drinks everyday, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding." ], "questions": [ "Questions or comments: 1 877 - 466 - 0294. Distributed by Migralex Inc. Larchmont, New York 10538 Made in Canada U.S. Patent #5538959, 5914129 TAMPER EVIDENT BOTTLE. DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS BROKEN OR MISSING" ], "spl_product_data_elements": [ "Migralex Dr. Mauskop Aspirin buffered with magnesium oxide aspirin aspirin magnesium oxide magnesium oxide M" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease asthma a magnesium-restricted diet bleeding problems stomach problems that last or come back (such as heartburn, upset stomach or stomach pain), or if you have ulcers." ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if allergic reaction occurs. Seek medical help right away. pain gets worse or lasts for more than 10 days new symptoms occur fever gets worse or lasts for more than 3 days ringing in the ears or a loss of hearing occurs redness or swelling is present" ], "storage_and_handling": [ "Directions Drink a full glass of water with each dose Adults and children 12 years and over: take 2 tablets every 6 hours while symptoms persist, but not more than 8 tablets in 24 hours, or as directed by a doctor Children under 12 years: ask a doctor Other Information store at room temperature read all product information before using save carton for full directions and warnings" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "image of carton label image of bottle label" ], "set_id": "31962eb9-690c-4727-852d-d6dfbf842c2a", "id": "0be179e8-6b58-424d-8af2-be237a80bc84", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active Ingredients (in each tablet) Aspirin 500 mg (Purpose: Pain Reliever) Buffered with Magnesium Oxide 75 mg" ] }, { "effective_time": "20130723", "inactive_ingredient": [ "Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain Reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy Alert : Magnesium salicylate may cause a severe allergic reaction, which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning : This product contains NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-426-9391" ], "spl_product_data_elements": [ "Extra Strength Backache Relief Magnesium Salicylate Tetrahydrate MAGNESIUM SALICYLATE SALICYLIC ACID HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;338" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults: 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours children under 12 years: do not use u nless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information each caplet contains: magnesium 50 mg store at controlled room temperature 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel FAMILY wellness ™ COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH DOAN'S® † Extra Strength Backache Relief Magnesium Salicylate Tetrahydrate 580 mg Pain Reliever 48 CAPLETS †This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Doan's®. 50844 ORG081033822 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC. 10401 MONROE RD, MATTHEWS NC 38105 USA Family Wellness 44-338 Family Wellness 44-338" ], "indications_and_usage": [ "Uses for the temporarily relief of minor backache pain" ], "set_id": "349fbda6-efc4-490e-84e7-04b381ec9bb8", "id": "206bf900-03e7-4233-9fd8-dc40e90fd239", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredients (in each caplet) Magnesium salicylate tetrahydrate 580 mg (NSAID)* (equivalent to 467.2 mg of anhydrous magnesium salicylate) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151019", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin" ], "purpose": [ "Purpose Nasal Decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? call 1-888-287-1915" ], "spl_product_data_elements": [ "Suphedrine Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE TRIACETIN 44;112" ], "ask_doctor": [ "Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions adults and children 12 years & over 2 tablets children 4 years to 12 years ask a doctor children under 4 years do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel equate® NDC 49035-112-08 Compare to Sudafed® Tablets Active Ingredient* Non-Drowsy Suphedrine Maximum Strength Nasal Decongestant Pseudoephedrine Hydrochloride Relieves: • Nasal and sinus congestion • Sinus pressure 12 DOSES 2 PILLS/DOSE 30 mg 24 TABLETS Actual Size TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0310B11208 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 © Wal-Mart Stores, Inc. Product Packaging Product Packaging" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "35878ac8-49e9-42a9-9781-b47b420ea287", "id": "a9249dbe-180c-4b62-9bb0-5f7d56948060", "active_ingredient": [ "Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years & over 2 tablets
children 4 years to 12 years ask a doctor
children under 4 years do not use
" ] }, { "effective_time": "20110217", "inactive_ingredient": [ "Inactive ingredients May contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow no. 10, FD&C yellow no. 6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax." ], "purpose": [ "Purpose Pain Reliever" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's Syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign or Reye's syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing) or shock. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ° are age 60 or older ° have had stomach ulcers or bleeding problems ° take a blood thinning (anticoagulant) or steroid drug ° take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ° have 3 or more alcoholic drinks every day while using this product ° take more or for a longer time than directed. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if ° the stomach bleeding warning applies to you ° you are taking a diuretic ° you have a history of stomach problems such as heartburn ° you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma. Ask a doctor or pharmacist before use if you are ° taking any other drug containing an NSAID (prescription or nonprescription) ° taking a blood thinning (anticoagulant) or steroid drug ° taking a prescription drug for diabetes, gout or arthritis. Stop use and ask a doctor if ° you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, an allergic reaction occurs. Seek medical help right away if pain gets worse or lasts more than 10 days, redness or swelling is present, fever gets worse or lasts more than 3 days, any new symptoms occur, or ringing in the ears or loss of hearing occurs. If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN CELLULOSE ACETATE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE RED METHACRYLIC ACID MINERAL OIL POLYDEXTROSE POLYSORBATE 80 PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BICARBONATE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE WHITE WAX T" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Drink a full glass of water with each dose. Swallow whole; do not chew or crush. Do not exceed recommend dose. Adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12: ask a doctor." ], "spl_unclassified_section": [ "Other Information Store at room temperature, 15°C - 30°C (59°F - 86°F). For institutional use only." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Aspirin EC 325mg" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains. Ask your doctor about other uses for aspirin." ], "set_id": "3599c90e-4cb0-475e-9d1e-8172c8ce014c", "id": "3599c90e-4cb0-475e-9d1e-8172c8ce014c", "active_ingredient": [ "Active ingredient Aspirin 325mg" ] }, { "effective_time": "20150709", "spl_unclassified_section_table": [ "
Ingredientes activos (en cada comprimido) Propósito
" ], "purpose": [ "Acetaminophen 500 mg ..........................................Pain reliever Pamabrom 25 mg ....................................................Diuretic Pyrilamine maleate15 mg........................................Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "when_using": [ "When using this product avoid alcoholic beverages drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery" ], "questions": [ "Questions or comments? 1-800-428-9489" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "indications_and_usage": [ "Uses for the temporary relief of these symptoms associated with menstrual periods: cramps headache bloating backache water-weight gain muscular aches irritability" ], "set_id": "39f4b936-612f-45f7-b4c3-c78c4e056e8b", "id": "91f6e47e-186e-454d-8d55-62edafb1b9bc", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Drug Facts Active ingredients (in each caplet) Purpose" ], "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: rash skin reddening blisters If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery Stop use and ask a doctor if redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "spl_product_data_elements": [ "Syncol Acetaminophen, Pamabrom, Pyrilamine Maleate ACETAMINOPHEN ACETAMINOPHEN PAMABROM BROMOTHEOPHYLLINE PYRILAMINE MALEATE PYRILAMINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN SYNCOL" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than the recommended dose adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur These could be signs of a serious condition." ], "spl_unclassified_section": [ "Datos del Medicamento Ingredientes activos (en cada comprimido) Propósito Acetaminofén 500 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alivio del dolor Pamabrom 25 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diurético Maleato de pirilamina 15 mg . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamínico Usos para el alivio temporal de estos síntomas asociados con los períodos menstruales: calambres dolores de cabeza irritabilidad aumento de peso por la retención de agua hinchazón dolores de espalda dolores musculares Advertencias Advertencia para el hígado: Este producto contiene acetaminofén. La dosis diaria máxima de este producto es de 6 comprimidos (3,000 mg) en 24 horas. Puede causar daño grave al hígado si toma más de 4,000 mg de acetaminofén en 24 horas otros medicamentos que contengan acetaminofén 3 o más bebidas alcohólicas cada día durante el uso de este producto. Alerta para alergias: Acetaminofén puede causar reacciones severas en la piel. Los síntomas pueden incluir: enrojecimiento de la piel ampollas sarpullidos Si su piel tiene una reacción, deje de usar el medicamento inmediatamente y busque ayuda médica. No usar con ningún otro medicamento que contenga acetominofén (con o sin receta). Si no está seguro si un medicamento contiene acetaminofén, consulte a un médico o farmacéutico. Consulte a un médico antes de usar si usted tiene ­una enfermedad hepática glaucoma dificultad para orinar debido al agrandamiento de la glándula de la próstata un problema respiratorio como enfisema o bronquitis crónica Pregunte a un médico o farmacéutico antes de usar si usted está tomando el anticoagulante warfarina tomando sedantes o tranquilizantes Al utilizar este producto puede haber somnolencia evite las bebidas alcohólicas puede haber excitabilidad, especialmente en los niños alcohol, sedantes y tranquilizantes pueden aumentar la somnolencia tenga cuidado al conducir un automóvil u operar maquinaria Suspenda el uso y consulte a un médico si el dolor empeora o dura más de 10 días la fiebre empeora o dura más de 3 días se presentan síntomas nuevos se presenta enrojecimiento o hinchazón Estas pueden ser señales de una condición seria. Si está embarazada o amamantando , consulte a un profesional de la salud antes de usar. Mantener fuera del alcance de los niños. En caso de sobredosis, obtenga atención médica inmediatamente o llame a un Poison Control Center (1-800-222-1222). Modo de Empleo no tome más de la dosis recomendada adultos y niños de 12 años y más: tome 2 comprimidos con agua cada 6 horas según sea necesario no exceda más de 6 comprimidos en un período de 24 horas, a menos que así lo indique un medico niños menores de 12 años: consulte a un médico Otra información ALTERACIóN EVIDENTE: NO USAR SI EL PAQUETE EXTERIOR ESTá ABIERTO O SI EL BLíSTER HA SIDO ROTO O RASGADO almacenar a 25° (77°F ); variaciones permitidas entre 15° - 30° C (59° - 86°F) vea el ala externa de la caja para la fecha de caducidad y número de lote Ingredientes inactivos almidón de maíz, croscarmelosa de sodio, crospovidona, hipromelosa, estearato de magnesio, celulosa microcristalina, polidextrosa, polietilenglicol, povidona, dióxido de silicio, ácido esteárico, dióxido de titanio, triacetín Preguntas y comentarios Llame Gratis al 1-800-428-9489" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
" ], "package_label_principal_display_panel": [ "PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 24 Capsules SYNCOL ® Acetaminophen / Pamabrom / Pyrilamine Maleate Pain Reliever / Diuretic / Antihistamine Multi-Symptom Relief of Premenstrual & Menstrual Pain including Menstrual Cramps Alivio Multi-síntomas de dolores Premenstruales y Menstruales incluyendo Cólicos Menstruales 24 Caplets / Comprimidos image description image description" ] }, { "effective_time": "20120521", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? call 1-877-446-3679 Mylan Pharmaceuticals Inc. Morgantown, WV 26505" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "set_id": "3f3576ca-8ed0-4f0e-bcf8-38dabb3bd1fe", "id": "6ffa08b1-f48a-45b8-95ce-9ed2672c4902", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient Cetirizine Hydrochloride 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Cetirizine Hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN M;C35" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other information store between 20° to 25°C (68° to 77°F)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief NDC 54868-5855-0 Cetirizine Hydrochloride Tablets 5 mg antihistamine 24 HOUR Relief of ITCHING Due to Hives Tamper Evident: do not use if foil seal under cap is missing, open or broken Cetirizine Hydrochloride Tablets 5 mg package label" ] }, { "effective_time": "20150224", "inactive_ingredient": [ "The mixed powder containing Lemon balm extract: ((Lemon balm extract(Switzerland), and Mulberry leaf extract(Korea)), Chicory root extract powder(Chile), Microcrystalline cellulose, Polydextrose, Hydroxypropylmethyl cellulose, Magnesium stearate, Stearic acid, Silicon Dioxide, Dry yeast(Se 0.1%), Zinc oxide, Dry yeast (Cr 0.2%), Nicotinamide, Glycerin esters of fatty acids, Calcium Pantothenate, Pyridoxine Hydrochloride, Thiamine Hydrochloride, Riboflavin, Cyanocobalamin" ], "purpose": [ "for body fat loss" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "1. Stop intake if an allergic reaction occurs. 2. Sedative effect may appear after intake 3. Children and pregnant or lactating women should be careful in intake." ], "spl_product_data_elements": [ "DR ANGIO Glycerin Glycerin Glycerin MAGNESIUM STEARATE SILICON DIOXIDE CALCIUM PANTOTHENATE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "for oral use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "take 1 tablet twice daily with plenty of water" ], "set_id": "443a14de-b29a-470e-a384-50b355f12a6a", "id": "f8475c40-6a2d-401b-ac98-7e5acc96fd87", "active_ingredient": [ "glycerin" ] }, { "effective_time": "20150504", "inactive_ingredient": [ "The mixed powder containing Lemon balm extract: ((Lemon balm extract(Switzerland), and Mulberry leaf extract(Korea)), Chicory root extract powder(Chile), Microcrystalline cellulose, Polydextrose, Hydroxypropylmethyl cellulose, Magnesium stearate, Stearic acid, Silicon Dioxide, Dry yeast(Se 0.1%), Zinc oxide, Dry yeast (Cr 0.2%), Nicotinamide, Glycerin esters of fatty acids, Pyridoxine Hydrochloride, Thiamine Hydrochloride, Riboflavin, Cyanocobalamin" ], "purpose": [ "for body fat loss" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "1. Stop intake if an allergic reaction occurs. 2. Sedative effect may appear after intake 3. Children and pregnant or lactating women should be careful in intake." ], "spl_product_data_elements": [ "DR ANGIO CALCIUM PANTOTHENATE CALCIUM PANTOTHENATE PANTOTHENIC ACID MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID angio tablet 3;hp;x" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "for oral use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "take 1 tablet twice daily with plenty of water" ], "set_id": "4680e3a4-eb02-4121-a3ad-a7a604637150", "id": "a7e3a46a-6da5-49a9-ad99-4617046aef2e", "active_ingredient": [ "CALCIUM PANTOTHENATE" ] }, { "effective_time": "20100607", "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Use: For preparation of skin before injection.", "Enter section text here" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Wipe Injection site vigorously and discard." ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20140301" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree Farenheat (15-30 degree Celcius)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Other Information: Store at 15 to 25 degree Celsius (59 to 77 degree Fahrenheit)" ], "set_id": "470991e3-cdab-4891-b8cd-382c24a7d1e5", "id": "3db06e79-e87f-4e44-ac20-c692118b932e", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Ethyl Alcohol 62 percent", "Genuine Hand Sanitizer Instant Gel Antiseptic Handwash with Vitamin E and Aloe Kills 99.9 percent of germs Without Water Active Ingredient: Ethyl Alcohol 62 percent Net Wt 0.9g (1/32 oz) Manufactured in China For Genuine First Aid." ], "pediatric_use": [ "Kit 25 Person" ], "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredient: Purified water." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings: For external use only.", "Warnings: For external use only Flammable, keep away from fire or flame" ], "spl_product_data_elements": [ "25 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSE LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSE POLYETHYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Genuine Hand Sanitizer Instant Antiseptic Handwash with Vitamin E and Aloe ALCOHOL ALCOHOL ALCOHOL" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions: Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours." ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with electrocautery, in the eyes.", "Do not use in the eyes. In case of contact, rinse eyes thoroughly with water." ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "IBUPROFEN 2 Tablets", "Ibuprofen", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Non Aspirin", "ASPIRIN 2 Tablets", "Aspirin 325mg", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Genuine Hand Sanitizer", "ANSI/ISEA Z308.1-2009 TYPE III Caution! This Kit meets ANSI/ISEA Z308.1-2009 only when required minimum fill is maintained with first aid products marked \"ANSI/ISEA Z308.1-2009.\" CARRYING CASE 1 Easy Access Pocket System 1 Hard Case POCKET1: SMALL CUTS AND BURNS 50 Adhesive Plastic Bandages 1\"x3\" 1 Knuckle Fabric Bandage 25Adhesive Spot Bandages 7/8\"X7/8\" 1Fingertrip Fabric Bandage 1 Elbow Knee Adhesive Bandage 6 Burn Cream 10Antiseptic Towelettes 6 Triple Antibiotic Ointment 0.5gr 20 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS AND SCRATCHES 10 Antiseptic Towelettes 4 Sterile Gauze Pad 3\"x3\" 2 Sterile Gauze Pads 4\"X4\" 2 Roller Gauze Bandage 2\"X4.1yds 1 Roller Gauze Bandage 3\"X4.1yds 1 Sterile Eye Pads 1 Sterile Eye Wash 10ml Twist Top 1 Butterfly Wound Closure, Medium POCKET 3: SEVERE BLEEDING AND BURNS 1 First Aid Tape Roll 1/2\"x5 yds. 1 Combine Pad 5\"X9\" POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5: PROTECTION 4 Medical Grade Vinyl Gloves 1 Instant Cold Compress 20 Alcohol Cleansing Pads 1 Hand Sanitizer 0.9g 1 Insect Sting Relief Pads 1 Triangular Bandage 42\"x42\"x59\" 2 Ibuprofen 200mg 2Non Aspirin 325mg 2 Aspirin 325mg POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID Copyright c 2010 Genuine First Aid LLC. All rights reserved." ] }, { "effective_time": "20121022", "purpose": [ "Purpose Pain Reliever/ Fever Reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed." ], "questions": [ "Questions or comments? Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "485d5fde-8e2b-4b54-9dc6-fdc9f17efc05", "id": "0720cdb6-3835-48a2-8530-c6f47a96142a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug." ], "active_ingredient": [ "Active Ingredient (in each caplet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purpose Pain Reliever/ Fever Reducer" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used. do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you: are age 60 or oder have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks everyday while using this prdouct take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed. Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic. Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug. When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used. do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor : Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use. Keep carton" ], "spl_product_data_elements": [ "Pain Relief Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN STARCH, CORN TITANIUM DIOXIDE IP;142" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic." ], "other_safety_information": [ "Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use. Keep carton" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used. do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor :" ], "stop_use": [ "Stop use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is present in the painful area Any new symptoms appear" ], "do_not_use": [ "Do not use if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Pain Relief Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID)* † Compare to the active ingredient in ADVIL® †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING", "Product Label Ibuprofen tablets 200 mg PLD Pain relief coated caplets" ], "warnings_table": [ "
Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used. do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ] }, { "effective_time": "20150528", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Enteric Safety Coated Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate DIMETHICONE SODIUM ALGINATE SODIUM BICARBONATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;414" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel RITE AID® PHARMACY **Compare to the Active Ingredient in St. Josephs® Adult Low Strength Aspirn LOW DOSE pain relief aspirin aspirin 81 mg pain reliever (NSAID) adult low dose aspirin regimen safety coated 500 ENTERIC COATED TABLETS **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark St. Josephs® Adult Low Strength Aspirn. 50844 ORG051241406 DISTRIBUTED BY: RITE AID 30 HUNTER LANE, CAMP HILL, PA 17011 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Rite Aid 44-414A Rite Aid 44-414A" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "49a28c05-85ce-4f43-b39a-d66c8021ca8c", "id": "8154e93b-2b8b-44ad-a82c-8ecce579d458", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150420", "inactive_ingredient": [ "Inactive Ingredients hypromellose*, lactose monohydrate, magnesium stearate, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl glycol*, povidone*, starch, talc* and titanium dioxide. *May also contain." ], "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine Ask doctor if you have  liver or kidney disease. Your doctor should determine if you need a different dose. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast Feeding  if breast-feeding: not recommended  if pregnant: ask a health professional before use." ], "when_using": [ "When using this product  drowsiness may occur  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase drowsiness  be careful when driving a motor vehicle or operating machinery" ], "spl_product_data_elements": [ "Allergy Relief Cetirizine HCl 10 mg CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES STARCH, CORN TALC TITANIUM DIOXIDE pillow-shaped 10MG;APO" ], "ask_doctor": [ "Ask doctor if you have  liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Adults and children 6 years and older One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney Ask a doctor disease" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast Feeding  if breast-feeding: not recommended  if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other information  store between 20°C to 25°C (68°F to 77°F )  do not use if safety seal under cap is open or missing", "Questions or comments Call toll free 1-888-952-0050 Manufactured for A&Z Pharmaceutical, Inc. Hauppauge, NY 11788" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Allergy relief Cetirizine 10 mg/ Antihistamine Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Carton Image" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat" ], "set_id": "4a144ecb-df2e-430d-844b-9fd02e3108d3", "id": "7eddcf87-1a06-4914-81fe-cbe8777388f3", "ask_doctor_or_pharmacist": [ "Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient Cetirizine HCl 10 mg" ] }, { "effective_time": "20101102", "inactive_ingredient": [ "Inactive Ingredients ma contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow #10 lake, FD&C yellow lake #6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax." ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "WARNINGS Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use • if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "QUESTIONS OR COMMENTS? Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63 Street, Brooklyn, New York 11204 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "ASPIRIN Aspirin ASPIRIN ASPIRIN POWDERED CELLULOSE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERRIC OXIDE RED METHACRYLIC ACID MINERAL OIL POLYDEXTROSE POLYSORBATE 80 PROPYLENE GLYCOL SILICON DIOXIDE SODIUM ALGINATE SODIUM BICARBONATE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;227" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and childre: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION store at 15° to 30°C (59° to 86°F)" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days redness or swelling is present any new symptoms appear ringing in the ears or loss of hearing occurs" ], "do_not_use": [ "Do not use • if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Package Label Blister of 30 Tablets Blister of 30 Tablets" ], "indications_and_usage": [ "USES Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever." ], "set_id": "4f9bd0b1-0836-473d-bf08-b7894984dc59", "id": "4f9bd0b1-0836-473d-bf08-b7894984dc59", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if taking a prescription drug for diabetes, gout or arthritis" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151105", "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain reliever/fever reducer Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI, ask a doctor or pharmacist before taking this product if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have heart disease liver disease high blood pressure diabetes thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days gever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Wal-Phed PE Acetaminophen, Diphenhydramine HCl, Phenyelphrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 44;544" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease liver disease high blood pressure diabetes thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than idrected (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take mroe than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days gever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "storage_and_handling": [ "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI, ask a doctor or pharmacist before taking this product if you have ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "Principal display panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDEDǂ NDC 0363-0544-09 NIGHTTIME Wal-Phed® PE PE Cold Acetaminophen 325 mg / Pain Reliever / Fever Reducer Diphenhydramine HCl 25 mg / Antihistamine Phenylephrine HCl 5 mg / Nasal Decongestant Relieves: • Sore throat • Head & body aches • Runny nose • Sinus pressure & congestion 20 CAPLETS Compare to Sudafed PE® Nighttime Cold active ingredientǂǂ PSEUDOEPHEDRINE FREE ǂWalgreens Pharmacist Survey Study, November 2010. ǂǂThis product is not manufactured or distributed by McNeil Consumer Health, Inc., owner of the registered trademark Sudafed® PE Nighttime Cold. 50844 REV0413A54409 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Walgreens 44-544 Walgreens 44-544" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache sore throat minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes" ], "set_id": "50c2ea03-859e-4af5-958c-54a40d38fdfb", "id": "4cc5f00b-d67a-4cf9-a113-57daacbb1dc1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplets) Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenyelphrine HCl 5 mg" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive ingredients corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silca, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experienece any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Enteric Coated Aspirin Aspirin ASPIRIN ASPIRIN STARCH, CORN D&C YELLOW NO. 10 HYPROMELLOSES METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SHELLAC SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE L" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "7", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experienece any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel Our Family® Quality Care Since 1904 Compare to the Active Ingredient of Bayer® Low Dose Aspirin† Low Strength Aspirin 81 mg Pain Reliever (NSAID) ADULT LOW STRENGTH ENTERIC COATED 500 TABLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY NASH FINCH COMPANY © 2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MLPS, MN 55435 †This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin. 50844 REV0613A60014 Our Family 44-600A Our Family 44-600A" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains or as recommended by your doctor" ], "set_id": "526029cc-aead-46f2-b213-707c0345497b", "id": "105217c2-26e5-4852-9d6c-890dfd67a554", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110117", "inactive_ingredient": [ "Inactive Ingredient: Purified water.", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredient: Purified water" ], "purpose": [ "Use: For preparation of skin before injection.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warning: For external use only." ], "when_using": [ "Wipe Injection site vigorously and discard.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "Genuine First Aid - Auto First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER" ], "description": [ "LOT/EXP: Made in CHINA 20140301", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Other information: Store at room temperature.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: with electrocautery, in the eyes.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "AlcoholCleansingPad", "APAP_PDP", "apap_pdp", "AUTO KIT FRONT", "AUTO KIT BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever" ], "set_id": "551965c6-022f-491b-8728-7e9fa9b64b78", "id": "63082ebc-35d7-4171-b4d3-5f0d76b217f7", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20121005", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-877-932-7948" ], "spl_product_data_elements": [ "Adult Low Strength Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate DIMETHICONE SODIUM ALGINATE SODIUM BICARBONATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;414" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30ºF (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 21130-414-12 Compare to St. Joseph® Adult Low Strength active ingredient† Adult Low Strength Aspirin 81 mg (NSAID) Aspirin Tablets, 81 mg • Enteric Coated • Pain Reliever 100 TABLETS SAFEWAY™ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0512B41412 DISTRIBUTED BY SAFEWAY INC. P.O. BOX 99, PLEASANTON, CA 94566-0009 Safeway 44-414A Safeway 44-414A" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "557d6bc1-5c15-4256-9819-fadd4bcd3d76", "id": "3daa78d7-f271-48da-8d46-eb3447779fe6", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110117", "inactive_ingredient": [ "Inactive Ingredient: Purified water.", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredient: Purified water" ], "purpose": [ "Use: For preparation of skin before injection.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warning: For external use only." ], "when_using": [ "Wipe Injection site vigorously and discard.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "Genuine First Aid - Home First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER" ], "description": [ "LOT/EXP: Made in CHINA 20140301", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Other information: Store at room temperature.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: with electrocautery, in the eyes.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "AlcoholCleansingPad", "APAP_PDP", "apap_pdp", "HOME KIT FRONT", "HOME KIT BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever" ], "set_id": "56269be0-68c6-41da-a43d-da4db593db0a", "id": "aca196dc-cdfb-4702-a04d-72a81b70d4d7", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20150528", "inactive_ingredient": [ "Inactive ingredients cellulose, colloidal silicon dioxidem croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-877-932-7948" ], "spl_product_data_elements": [ "Adult Low Strength Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate DIMETHICONE SODIUM ALGINATE SODIUM BICARBONATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;414" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30ºF (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel DG ™ health Compare to the active ingredient in St. Joseph ® Adult Low Strength Aspirin† Adult Low Strength ASPIRIN Pain Rliever (NSAID) 81 mg Safety Coated Aspirin Regimen 100 Enteric Coated Tablets †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark St. Joseph ® Adult Low Strength Aspirin. 50844 ORG051241412 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Dollar General 44-414 Dollar General 44-414" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "5af9a257-0201-488e-a27f-7b775c9ce424", "id": "0ed0e7f2-3cf5-4c77-b5b9-d18c886082a4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141209", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose* polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin*" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-234-1464" ], "spl_product_data_elements": [ "MooreBrand Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 20-25°C (68-77°F) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "100R MM Ibuprofen Label moore medical Supporting Health and Care Reorder No. 82471 UPN# 0-0607415-82471-1 Moore Brand® Ibuprofen 200 mg (NSAID) 200 Packets/2 Tablets Each Packet Net Wt. 400 mg For the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps and for the reduction of fever 100R MM Ibuprofen Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "5b37df65-e81e-44ca-948d-0cf415f97082", "id": "09ccd60b-3d2c-0c82-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110419", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? call 1-800-282-3000" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information store at controlled room temperature avoid excessive heat 40°C (104°F)" ], "indications_and_usage": [ "Use temporarily relieves minor aches and pains due to: headache the common cold toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily relieves fever" ], "set_id": "5c6f50e7-d309-4e47-9ee4-22503b00be3e", "id": "8fe03304-24d2-48d5-8f51-c4db514f704d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each white tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive ingredients cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) skin reddening shock rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product" ], "spl_product_data_elements": [ "CounterAct IB Ibuprofen IBUPROFEN IBUPROFEN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN White Round 44;352" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "boxed_warning": [ "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "image of label", "image of box" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-356-0783" ], "spl_product_data_elements": [ "Rapid Comfort Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN IBUPROFEN IBUPROFEN WHITE ROUND 44;352" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel – Carton Label Rapid Comfort ™ Ibuprofen 200 mg USP (NSAID) Easy To Swallow Film-Coated Tablets Fácil de Tragar Tabletas con Capa Ultradelgada Compare active ingredient to: Advil ® Registered trademark of Pfizer Consumer Healthcare Pull to Open 500 Tablets (250 x 2s) Tamper-Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias Principal Display Panel – Carton Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "61536a76-1138-44f4-9720-f1a892243bf7", "id": "0c3b148b-f2a2-3a0e-e054-00144ff88e88", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120306", "spl_unclassified_section_table": [ "
adults and children 12 years & over 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS cellulose, croscarmellose sodium, dicalcium phosphate, FD&C red #40, FD&C yellow #6, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin" ], "purpose": [ "PURPOSE Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away" ], "warnings": [ "WARNINGS Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes thyroid disease heart disease high blood pressure trouble urinating due to enlargement of the prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with fever If pregrant or breast-feeding, ask a health professional before use." ], "spl_product_data_elements": [ "SudoGest Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride Pseudoephedrine Croscarmellose Sodium FD&C YELLOW NO. 6 HYPROMELLOSES Magnesium Stearate Polydextrose POLYETHYLENE GLYCOLS Titanium Dioxide Triacetin 44112" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "" ], "spl_unclassified_section": [ "DRUG FACTS", "Directions take every 4 to 6 hours do not exceed 4 doses in 24 hours adults and children 12 years & over 2 tablets children 6 to under 12 years 1 tablet children under 6 years ask a doctor" ], "storage_and_handling": [ "OTHER INFORMATION store at controlled room temperature 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Sudogest 30mg (Nasal Decongestant)" ], "indications_and_usage": [ "USES temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis temporarily relieves sinus congestion and pressure" ], "set_id": "656726ed-50cd-4f7e-8e51-e242afd1d9c9", "id": "656726ed-50cd-4f7e-8e51-e242afd1d9c9", "active_ingredient": [ "Active Ingredient (in each tablet) Pseudoephedrine HCl 30 mg" ] }, { "effective_time": "20120514", "purpose": [ "Purpose Pain Reliever/ Fever Reducer" ], "keep_out_of_reach_of_children": [ "keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "when_using": [ "when using this product take food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions? (866) 562-2756 Adverse drug event call:" ], "pregnancy_or_breast_feeding": [ "if pregnant or breast feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "other information store between 20 - 25 C (68 - 77 F) o o o o avoid high humidity and excessive heat above 40 C (104 F) o o : do not use if imprinted seal under the cap is broken or missing Tamper Evident" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pain due to temporarily reduces fever minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches" ], "set_id": "687e0308-7809-4b97-a888-833dd13c2000", "id": "5cd60c24-a29c-4a54-ba36-b0ffcf3db46f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active Ingredient (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take one tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow# 10, FD & C blue# 2, FD & C red# 40, FD & C yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you hives facial swelling asthma (wheezing) shock skin reddening rash blisters are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POLYSORBATE 80 FERRIC OXIDE RED TITANIUM DIOXIDE IBU200" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take one tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "stop_use": [ "stop use and ask a doctor if you experience any of the following signs of stomach bleeding pain gets worse or last for more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear feel faint vomit blood have bloody or black stools have stomach pain that does not get better" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "IBUPROFEN TABLET, FILM COATED Label Image" ] }, { "effective_time": "20150224", "inactive_ingredient": [ "Lemon balm extract, Mulberry leaf extract, and Artemisia extract, Chicory root extract powder, microcrystalline cellulose, polydextrose, hydroxypropylmethyl cellulose, magnesium stearate, stearic acid, silicon dioxide, dry yeast(Se 0.1%), zinc oxide, dry yeast (Cr 0.2%), nicotinamide, glycerin esters of fatty acids, calcium pantothenate, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin, cyanocobalamin" ], "purpose": [ "for reducing body fat, especially abdominal fat and liver fat" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "1. Stop intake if an allergic reaction occurs. 2. Children and pregnant or lactating women should be careful in intake." ], "spl_product_data_elements": [ "OB-X Glycerin Glycerin Glycerin MAGNESIUM STEARATE SILICON DIOXIDE CALCIUM PANTOTHENATE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "for oral use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "take 1 tablet twice daily with plenty of water" ], "set_id": "69b04d5e-5938-4e15-b006-6204b528d1b9", "id": "a4e61dd9-2d79-49ff-b521-dfeb130e55b2", "active_ingredient": [ "glycerin" ] }, { "effective_time": "20130517", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonite, sodium lauryl sulfate. talc, titanium dioxide, triacetin, triethyl cellulose" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate DIMETHICONE SODIUM ALGINATE SODIUM BICARBONATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;414" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºF (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDEDǂ VALUE SIZE NDC 0363-0414-14 ENTERIC COATED • LOW DOSE Aspirin 81 81 mg / Pain Reliever (NSAID) 500 ENTERIC COATED TABLETS Compare to St. Joseph® Adult Low Strength Aspirin active ingredientǂǂ NOT FOR HOUSEHOLDS WITHOUT CHILDREN ǂWalgreens Pharmacist Survey Study, November 2012 ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark St. Joseph® Adult Low Strength Aspirin. 50844 ORG051241414 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Walgreens 44-414A Walgreens 44-414A" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "6b838a70-d46f-4b9b-9530-a906764dee6d", "id": "9c5d8aae-939c-4d6f-b730-792370876cf3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredient: Purified water." ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Use: For preparation of skin before injection.", "Enter section text here" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings: For external use only.", "Warnings: For external use only Flammable, keep away from fire or flame" ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Wipe Injection site vigorously and discard." ], "spl_product_data_elements": [ "50 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSE LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSE POLYETHYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Genuine Hand Sanitizer Instant Antiseptic Handwash with Vitamin E and Aloe ALCOHOL ALCOHOL ALCOHOL" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20140301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "13", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions: Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.", "Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree Farenheat (15-30 degree Celcius)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Other Information: Store at 15 to 25 degree Celsius (59 to 77 degree Fahrenheit)" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with electrocautery, in the eyes.", "Do not use in the eyes. In case of contact, rinse eyes thoroughly with water." ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "IBUPROFEN 2 Tablets", "Ibuprofen", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Non Aspirin", "ASPIRIN 2 Tablets", "Aspirin 325mg", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AlcoholCleansingPad", "Genuine Hand Sanitizer", "ANSI/ISEA Z308.1-2009 TYPE III Caution! This Kit meets ANSI/ISEA Z308.1-2009 only when required minimum fill is maintained with first aid products marked \"ANSI/ISEA Z308.1-2009.\" CARRYING CASE 1 Easy Access Pocket System 1 Hard Case POCKET 1: SMALL CUTS AND BURNS 100 Adhesive Plastic Bandages 1\"x3\" 2 Knuckle Fabric Bandage 25 Adhesive Spot Bandages 7/8\"X7/8\" 2 Fingertip Fabric Bandage 2 Elbow Knee Adhesive Bandage 6 Burn Cream 15 Antiseptic Towelettes 6 Triple Antibiotic Ointment 0.5gr 40 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS AND SCRATCHES 15 Antiseptic Towelettes 4 Sterile Gauze Pad 3\"x3\" 4 Sterile Gauze Pads 4\"X4\" 2 Roller Gauze Bandage 2\"X4.1yds 1 Roller Gauze Bandage 3\"X4.1yds 2 Sterile Eye Pads 2 Sterile Eye Wash 10ml Twist Top 1 Butterfly Wound Closure, Medium POCKET 3: SEVERE BLEEDING AND BURNS 2 First Aid Tape Rolls 1/2\"x5 yds. 2 Combine Pad 5\"X9\" POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5: PROTECTION 4 Medical Grade Vinyl Gloves 1 Instant Cold Compress 30 Alcohol Cleansing Pads 1 Hand Sanitizer 0.9g 2 Insect Sting Relief Pads 2 Triangular Bandage 42\"x42\"x59\" 2 Ibuprofen 200mg 2 Non Aspirin 325mg 4 Aspirin 325mg POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID Copyright c 2010 Genuine First Aid LLC. All rights reserved.", "ANSI Kit 50 Persons" ], "set_id": "6bd126f0-967e-47d2-82d8-1c90f69aca5d", "id": "2a883d44-4542-4a0e-8202-6a70e159ee52", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient: Purpose Isopropyl Alcohol, 70% v/v............... Antiseptic", "Active Ingredient: Ethyl Alcohol 62 percent", "Genuine Hand Sanitizer Instant Gel Antiseptic Handwash with Vitamin E and Aloe Kills 99.9 percent of germs Without Water Active Ingredient: Ethyl Alcohol 62 percent Net Wt 0.9g (1/32 oz) Manufactured in China For Genuine First Aid." ] }, { "effective_time": "20111227", "purpose": [ "Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "keep out of reach of children In case of overdose, get medical help or contact a poison control center right away. This package is not for households with young children." ], "when_using": [ "when using this product take food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions? Adverse drug event call: (800)687-0176 *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark ADVIL ® ." ], "pregnancy_or_breast_feeding": [ "if pregnant or breast feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "other information store between 20 o - 25 o C (68 o - 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F)" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pain due to minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches temporarily reduces fever" ], "set_id": "6c218f12-c4e8-4fe6-aefd-3fe5221243e9", "id": "13daa2c3-6403-4379-9be0-5646677fa9a2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active Ingredient (In each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DC yellow# 10, FDC blue# 2, FDC red# 40, FDC yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POLYSORBATE 80 FERRIC OXIDE RED TITANIUM DIOXIDE 2I" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "stop_use": [ "stop use and ask a doctor if you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or last for more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Ibuprofen 200 mg (NSAID)* NDC 54868-0984-4 Additional bar code label applied by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146 SDA Ibuprofen 200 mg Brown Tablet" ] }, { "effective_time": "20130110", "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Purpose Analgesic/antipyretic", "Purpose Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "description": [ "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other information: Store at room temperature.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59-86 degree F (15-30 degree C)", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)" ], "indications_and_usage": [ "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Use For preparation of skin before injection." ], "set_id": "7a9d67cc-136b-4c94-abc5-f56460bc4e5d", "id": "c5160f28-9ec8-4ea0-b7de-30e215a4f371", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient (in each tablet) Acetaminophen 325 mg", "Active Ingredient Active Ingredient: Isopropyl Alcohol, 70% v/v" ], "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredient: Purified water", "Inactive Ingredients Cornstarch, polyethylene glycol, stearic acid, povidone", "Inactive Ingredient Purified water." ], "warnings": [ "Warnings: For external use only.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warning: For external use only.", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings For external use only." ], "spl_product_data_elements": [ "Ready America First Aid Pocket - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOLS STEARIC ACID POVIDONE White AZ;234 Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOLS PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions Wipe Injection site vigorously and discard." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor." ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20140301" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use in the eyes or over large areas of the body.", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: with electrocautery, in the eyes." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID 100 Alcohol cleansing pads Reorder GFAP-39-02", "AntisepticTowelette", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "Alcohol Cleansing Pad", "Non Aspirin", "Kit Label" ] }, { "effective_time": "20110209", "spl_unclassified_section_table": [ "
Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
Children under 12 years ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Brown Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch Corn, Titanium Dioxide Orange Tablets: Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, FD&C Yellow #6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide" ], "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma(wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "spl_product_data_elements": [ "Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen (NSAID) IBUPROFEN IBUPROFEN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IP;140" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "" ], "spl_unclassified_section": [ "Drug Facts", "USES temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever", "DIRECTIONS do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor Children under 12 years ask a doctor", "OTHER INFORMATION Store between 20 - 25°C (68 - 77°F) Read all warnings and directions before use", "Questions or Comments Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST. *Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil ®", "Distributed By: Ameal Pharmaceuticals Glasgow, KY 42141 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Ibuprofen 200mg" ], "indications_and_usage": [ "" ], "set_id": "7b4858fc-fea6-4e4c-886e-a2febe1ed2c3", "id": "7b4858fc-fea6-4e4c-886e-a2febe1ed2c3", "active_ingredient": [ "ACTIVE INGREDIENT (in each tablet) Ibuprofen USP, 200 mg (NSAID)** **nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only.", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed" ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor" ], "spl_product_data_elements": [ "10 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSE LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSE POLYETHYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear" ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Other information: Store at room temperature.", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree Farenheat (15-30 degree Celcius)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Antiseptic Towelette", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "GenuineTripleAntibiotic", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "GenuineEyeWash", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "IBUPROFEN 2 Tablets", "Ibuprofen", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Non Aspirin", "ASPIRIN 2 Tablets", "Aspirin 325mg", "ANSI/ISEA Z308.1-2009 TYPE III Caution! This Kit meets ANSI/ISEA Z308.1-2009 only when required minimum fill is maintained with first aid products marked \"ANSI/ISEA Z308.1-2009.\" CARRYING CASE 1 Easy Access Pocket System 1 Hard Case POCKET1: SMALL CUTS AND BURNS 16 Adhesive Plastic Bandages 1\"x3\" 1 Burn Cream 5 Antiseptic Towelettes 6 Triple Antibiotic Ointment 0.5gr 10 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS AND SCRATCHES 5 Antiseptic Towelettes 4 Sterile Gauze Pad 3\"x3\" 1 Roller Gauze Bandage 2\"X4.1yds 1 Sterile Eye Pads 1 Sterile Eye Wash 10ml Twist Top POCKET 3: SEVERE BLEEDING AND BURNS 1 First Aid Tape Roll 1/2\"x5 yds. 1 Combine Pad 5\"X9\" POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5: PROTECTION 2 Medical Grade Vinyl Gloves 1 Insect Sting Relief Pads 1 Triangular Bandage 42\"x42\"x59\" 2 Ibuprofen 200mg 2Non Aspirin 325mg 2 Aspirin 325mg POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 1 Plastic Tweezers 1 Scissors Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID Copyright c 2010 Genuine First Aid LLC. All rights reserved.", "10 Person ANSI Kit" ], "set_id": "7d1950b4-3237-4512-bab3-4c7364bdd618", "id": "fd9dd0ed-a7e0-44c8-9c21-4b03b32f8cad", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141209", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose* polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* * may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-234-1464" ], "spl_product_data_elements": [ "Moore Medical Ibuprofen Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug Purpose Pain reliever/fever reducer Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever. Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose* polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* * may contain Questions or comments? 1-800-234-1464" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "100R MM Ibuprofen Label moore medical Supporting Health and Care Reorder No. 82471 UPN# 0-0607415-82471-1 Moore Brand® Ibuprofen 200 mg (NSAID) 200 Packets/2 Tablets Each Packet Net Wt. 400 mg For the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps and for the reduction of fever Principal Display Panel - Packet Net Wt. 400 mg" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache backache common cold minor arthritis pain toothache menstrual cramps muscular aches Temporarily reduces fever." ], "set_id": "7d54d13d-746a-42ed-a30d-d968b6c13f54", "id": "09cc5c22-4a33-504e-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151103", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "OTC - PURPOSE SECTION Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN SECTION Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS SECTION Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "OTC - WHEN USING SECTION do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "questions": [ "OTC - QUESTIONS SECTION (800) 616-2471" ], "spl_product_data_elements": [ "IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;291" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "information_for_patients": [ "INFORMATION FOR PATIENTS SECTION store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "84d86fd2-24c4-438f-a8ba-2002b10bacdf", "id": "d1a72438-19cf-45ad-8349-c4676ec31483", "active_ingredient": [ "OTC - ACTIVE INGREDIENT SECTION Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20140610", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665 : weekdays 8:00 AM to 8:00 PM EST" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see end panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "set_id": "8c8642ef-ae86-4de5-8869-e608105454d6", "id": "62590ee3-7fa4-47dd-862c-1cc9355f387d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, iron oxide, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Motrin IB Ibuprofen Ibuprofen Ibuprofen carnauba wax silicon dioxide starch, corn FD&C yellow NO. 6 hypromelloses ferric oxide red magnesium stearate polydextrose polyethylene glycols propylene glycol shellac stearic acid titanium dioxide Motrin;IB" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "spl_unclassified_section": [ "Important Read all product information before using. Keep this box for important information.", "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-109-04 Motrin ® IB Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID) 100 Coated Tablets Principal Display Panel" ] }, { "effective_time": "20120719", "inactive_ingredient": [ "Inactive ingredients hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylprrolidone, pregelatinzed starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides" ], "purpose": [ "Purpose Pain reliever", "Purpose Pain reliever aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Reye’s syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction which may include: hives facial swelling shock asthma (wheezing) Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning : The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine – containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic high blood pressure you have asthma Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or non-prescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children." ], "questions": [ "Questions 1-866-255-5197 GoodysPowder.com" ], "spl_product_data_elements": [ "Goodys PM Pain Reliever Acetaminophen and Aspirin and Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE HYPROMELLOSES MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE STARCH, CORN SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE 2793" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic high blood pressure you have asthma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) drink a full glass of water with each dose adults and children 12 years and over : take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years of age : ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at 68ºF – 77ºF (20ºC – 25ºC)" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Goody’s EXTRA STRENGTH Acetaminophen ● Aspirin (NSAID)/ Caffeine Pain Reliever ● Pain Reliever Aid 100 Caplets PRINCIPAL DISPLAY PANEL Goody’s EXTRA STRENGTH" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to headache minor arthritis pain muscle aches colds" ], "set_id": "8d4fc971-492d-471d-a3c2-7d8e2237a5f3", "id": "1af3c28a-0ba0-4036-b5c4-51a96dd9ba42", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or non-prescription) a blood thinning (anticoagulant) or steroid drug a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms." ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin (NSAID**) 250 mg **nonsteroidal anti-inflammatory drug", "Active ingredient (in each caplet) Caffeine 65 mg" ] }, { "effective_time": "20140424", "purpose": [ "Purpose Pain reliever/fever reducer Antihistamine Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-282-3000" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever and the common cold: runny nose nasal congestion headache sore throat minor aches and pains sneezing temporarily relieves these symptoms of hay fever: itching of the nose or throat itchy, watery eyes temporarily reduces fever" ], "set_id": "8e2d4784-732e-401e-98a9-0310896a6ad5", "id": "0279280a-c07a-4796-963b-6ae324d61055", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 5 mg" ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, crospovidone, FD and C blue No. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, starch, stearic acid, titanium dioxide, triacetate, triacetin" ], "warnings": [ "Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product" ], "spl_product_data_elements": [ "CounterAct Night Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI ACETAMINOPHEN ACETAMINOPHEN CELLULOSE, MICROCRYSTALLINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 1 STEARIC ACID HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE STARCH, CORN TITANIUM DIOXIDE TRIACETIN Blue Capsule shaped 44;544" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease liver disease high blood pressure diabetes thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "boxed_warning": [ "TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "stop_use": [ "These could be signs of a serious condition Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you ever had an allergic reaction to this product or any of its ingredients" ], "package_label_principal_display_panel": [ "image of blister", "image of box" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20150505", "drug_interactions": [ "DRUG INTERACTIONS: Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced serum folate levels have occurred in some patients taking pancreatic extracts, such a pancreatin and pancrelipase. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folinic acid may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study. Drugs which may interact with vitamin B 12 (Methylcobalamin): Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B 12 . Nitrous oxide can produce a functional vitamin B 12 deficiency" ], "inactive_ingredient": [ "Other ingredients: Sodium Citrate Dihydrate, Citric Acid, Microcrystalline Cellulose (MCC), Dicalcium Phosphate, Croscarmellose Sodium, Hydroxypropyl Cellulose (Modified Cellulose), Stearic Acid, Magnesium Stearate, Silicon Dioxide, Cellulose, Titanium Dioxide, Polydextrose, Talc, Maltodextrin, Triglycerides, Carmine, Food Glaze, Polyethylene Glycol, Micro Wax and other ancillary ingredients as needed to ensure product stability. Since additives, preservatives, bioavailability enhances, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality. Warning: Carmine - haram for Mulsims." ], "contraindications": [ "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated." ], "references": [ "REFERENCES: Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2. Federal Register Notice of April 9, 1971 (36 FR 6843). The Federal Register Notice of August 2, 1973 (38 FR 20750). The Federal Register Notice of October 17, 1980 (45 FR 69044). The Federal Register Notice of August 2, 1973 (38 FR 20750). Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000. The Federal Register Notice of March 5, 1996 (61 FR 8760). Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000. Code of Federal Regulations Title 21 Section 172.345. Code of Federal Regulations Title 21 Section 101.9(j)(8). Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7." ], "precautions": [ "PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress." ], "warnings": [ "WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study. 13 Patients undergoing cancer treatment should consult their licensed medical practitioner for advice." ], "pregnancy": [ "PREGNANCY and NURSING MOTHERS: Virt-Vite Forte Tablets is not intended for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. This product contains B vitamins in reduced form. Talk with your medical practitioner before using if pregnant or lactating." ], "spl_product_data_elements": [ "Virt-Vite Forte folic acid, pyridoxine hydrochloride and cyanocobalamin FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN TRISODIUM CITRATE DIHYDRATE CITRIC ACID MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (TYPE H) STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE POWDERED CELLULOSE TITANIUM DIOXIDE POLYDEXTROSE TALC MALTODEXTRIN C10-18 TRIGLYCERIDES PIGMENT RED 48 POLYETHYLENE GLYCOLS MICROCRYSTALLINE WAX V201" ], "description": [ "DESCRIPTION: Virt-Vite Forte Tablets is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. Virt-Vite Forte Tablets should be administered under the supervision of a licensed medical practitioner. Each round coated pink tablet contains the following dietary ingredients: Supplement Facts Serving Size: 1 Tablet Servings per Container: 90 Amount per Serving % Daily Value Folic acid (vitamin B 9 ) 2.5 mg Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner. Pyridoxine HCl (vitamin B 6 ) 25 mg Cyanocobalamin (vitamin B 12 ) 2 mg" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: One to two tablets daily or as directed by a licensed medical practitioner." ], "adverse_reactions": [ "ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine. Call your medical practitioner about side effects." ], "spl_unclassified_section": [ "Prescription Dietary Supplement Rx", "FOLATE MECHANISM OF ACTION: FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.", "FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood 4,5,6 . Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that \"The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added] 9,10\" . The actual amount and source of folate require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that \"dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated ... When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added] 7 .\" However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (R x )-folate regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345) 11 . In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B 6 , and Vitamin B 12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote \"... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B 12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B 12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B 12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added] 8 .\" Summary: This product is a dietary management product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.", "ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.", "INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product .", "PHARMACOLOGY: FOLATE - Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. 3 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the \"methyl trap\" hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate 10 . Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate 10 .", "KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.", "KEEP THIS OUT OF REACH OF CHILDREN. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344. NDC: This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications. 76439-201-90", "This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable. R x", "Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL. 33619 MADE IN USA Virtus PHARMACEUTICALS Rev. 11/13" ], "storage_and_handling": [ "STORAGE: Store at Controlled Room Temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container." ], "how_supplied": [ "HOW SUPPLIED: Virt-Vite Forte Tablets are round coated pink tablets debossed on one side with \"V201\", and are supplied in bottles of 90 tablets. STORAGE: Store at Controlled Room Temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Virtus PHARMACEUTICALS Product Code: 76439- 201 -90 Virt-Vite Forte Tablets Prescription Dietary Supplement R x 90 Tablets PRINCIPAL DISPLAY PANEL - 30 tablets" ], "indications_and_usage": [ "INDICATIONS AND USAGE: Virt-Vite Forte Tablets is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Virt-Vite Forte Tablets should be administered under the supervision of a licensed medical practitioner." ], "set_id": "924426c6-53c1-478c-ba34-058c18bd9c62", "id": "3fe93e33-ea94-40a0-8a4c-6ffe95ab3e9e", "description_table": [ "
Supplement Facts
Serving Size: 1 Tablet Servings per Container: 90
Amount per Serving % Daily Value
Folic acid (vitamin B9) 2.5 mg Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Pyridoxine HCl (vitamin B6) 25 mg
Cyanocobalamin (vitamin B12) 2 mg
" ] }, { "effective_time": "20150107", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-634-7680" ], "spl_product_data_elements": [ "MEDIQUE I-PRIN Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 MEDI-FIRST Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 MEDI-FIRST PLUS Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 Dover Addaprin Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115 Otis Clapp Ultraprin Ibuprofen CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN white ROUND 115" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Marksans Pharma Limited 925822975 100R Medique Iprin Label Collect MediBucks See inside flap for more details Medique® I-Prin Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Alivia el Dolor/Reduce la Fiebre (AINE) Easy To Swallow Film Coated Tablets Facil de Tragar Tabletas con Cubierta Pelicular Pull to Open Tire Para Abrir 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias 100R MF Ibuprofen Label 100 tablets (50 x 2) Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Pull to Open Easy To Swallow Film Coated Tablets Compare active ingredient to: Genuine Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets 100R MFP Ibuprofen Label 100 tablets (50 x 2's) Medi-First® Plus Ibuprofen 200 mg USP Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets Compare active ingredient to: Advil® Registered Trademark of Pfizer Consumer Healthcare Tamper Evident Unit Dose Packets 100R Dover Addaprin Label Dover Addaprin™ Pain Reliever-Fever Reducer Ibuprofen 200 MG. Tablets (NSAID) Dover Pharmaceutical Products of the highest quality and effectiveness Tamper Resistant Sealed Packets Unit Dose Packs 500 Tablets (250 Packets of 2) 100R OC Ultraprin Label OC Otis Clapp Quality & Integrity Since 1840 Ultraprin ™ Pain Reliever-Fever Reducer (NSAID) Ibuprofen Tablets USP 200 mg For Deep Seated Pain See Warnings and Directions on Side Panel Tear Out Along Perforation To Dispense Professional Healthcare 500 Tablets (250 Packets of 2) ibu09-0000-01 Medique Iprin ibu09-0000-02 Medi-First Ibuprofen ibu09-0000-03 MFP Ibuprofen ibu09-0000-04 Dover Addaprin ibu09-0000-05 Otis Clapp Ultraprin" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "9421052a-f363-47fb-8ca7-022a1815c830", "id": "09c92093-894d-6de9-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110413", "purpose": [ "Purpose Antiseptic", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Purpose Triple Antibiotic", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product: take with food or milk if stomach upset occurs" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Flammable - keep away from fire or flame.", "Other information: Store at room temperature.", "Store at 59-86 degree F (15-30 degree C)", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets" ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns" ], "set_id": "9509f867-19c5-4661-bda9-7a9275f1e0cf", "id": "c7ffd563-e629-424b-af33-1730ea9bafc5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin." ], "warnings": [ "Warnings Warning: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings For external use only.", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed" ], "spl_product_data_elements": [ "Easy Care First Aid Kit - Outdoor and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352" ], "ask_doctor": [ "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear" ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery." ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "Genuine Triple Antibiotic", "Non Aspirin", "Anitseptic Towelette", "Insect Sting Relief Pad", "Ibuprofen 200mg", "On The Go First Aid" ] }, { "effective_time": "20120822", "inactive_ingredient": [ "Inactive ingredients cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate." ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "In case of overdose , get medical help or contact a Poison Control Center right away. Keep out of reach of children." ], "warnings": [ "Warnings This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Reye's Syndrome: Aspirin may cause a severe allergic reaction which may include: Allergy Alert: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use Ask a doctor before use if the stomach bleeding warning applies to you you are taking a diuretic you have a history of stomach problems, such as heartburn you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug taking a prescription drug for diabetes, gout or arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away pain gets worse or lasts more than 10 days redness or swelling is present fever gets worse or lasts more than 3 days any new symptoms occur ringing in the ears or loss of hearing occurs If pregnant or breast-feeding, In case of overdose , get medical help or contact a Poison Control Center right away. Keep out of reach of children." ], "spl_product_data_elements": [ "Adult Low Dose Enteric Coated Aspirin Aspirin ASPIRIN ASPIRIN FERROSOFERRIC OXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE DIMETHICONE SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE L" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions drink a full glass of water with each dose swallow whole, do not chew or crush do not exceed recommended dose adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor children under 12 years: ask a doctor" ], "storage_and_handling": [ "Other information store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F) for institutional use only" ], "package_label_principal_display_panel": [ "ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED Label Image" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains ask your doctor about other uses for aspirin" ], "set_id": "95c34d67-3a72-49d4-89aa-7186ac58c0dc", "id": "1fcb1187-31a2-413d-9edd-85bcd07aacec", "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120327", "purpose": [ "Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "keep out of reach of children In case of overdose, get medical help or contact a poison control center right away. This package is not for households with young children." ], "when_using": [ "when using this product take food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions? Adverse drug event call: (800)687-0176 *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark ADVIL ® ." ], "pregnancy_or_breast_feeding": [ "if pregnant or breast feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "other information store between 20 o - 25 o C (68 o - 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F)" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pain due to minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches temporarily reduces fever" ], "set_id": "98a219ab-aa30-46cb-ac13-5c9095a75b40", "id": "98a219ab-aa30-46cb-ac13-5c9095a75b40", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active Ingredient (In each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 tablet every4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive Ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DC yellow# 10, FDC blue# 2, FDC red# 40, FDC yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non prescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POLYSORBATE 80 FERRIC OXIDE RED TITANIUM DIOXIDE 2I" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "stop_use": [ "stop use and ask a doctor if you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or last for more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Ibuprofen 200mg" ] }, { "effective_time": "20111114", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide, corn starch*, hypromellose, iron oxide red*, lactose, magnesium stearate, microcrystalline cellulose*, polydextrose, polyethylene glycol, povidone, silica*, sodium lauryl sulfate*, sodium starch glycolate, stearic acid*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-356-9100" ], "spl_product_data_elements": [ "Conney Ibuprofen Ibuprofen Ibuprofen Ibuprofen CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE ROUND 44;352" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Conney Ibuprofen Label Conney ® Ibuprofen Pain Reliever/Fever reducer Ibuprofen 200 mg. (NSAID) Ibuprofeno 200 mg. (AINE) Lightly Coated Industrial Pack 500 (250 Packets of 2 Tablets) Carton Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "9cc5fcf5-3fb2-4f87-884c-241f76c1fa6e", "id": "9b9251d5-3362-4218-aa4e-7a694968b228", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20101206", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Purpose: Antihistimine", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warnings Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are: taking any drugs for asthma taking sedatives or tranquilizers", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "When using this product Drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitaility may occur, especially in children", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-4 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE DIPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 STARCH, CORN PINK WHITE CPC;835 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: do not give to children under 12 years of age unless directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967", "Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "DIPHEN_PDP", "DIPHEN_PANEL", "TWOPERSONKIT_FRONT", "TWOPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever", "Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes" ], "set_id": "9fcaff71-ca36-4f96-b252-a73607de19f9", "id": "b2a273a1-92fa-474f-afc9-1620960ee4e1", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient (in each tablet) Purpose Diphenhydramine Hydrochloride 25mg............................... Antihistimine", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20120711", "purpose": [ "Purpose Antiseptic", "Purpose Triple Antibiotic", "Purpose Purpose: First aid antiseptic, external analgesic", "Purpose Pain reliever/fever reducer", "Purpose Analgesic/antipyretic", "Purpose Pain Reliever / fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs" ], "description": [ "LOT/EXP: Made in CHINA 20130301 GFA Production Xiamen Co., Ltd No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100 Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other information: Store at room temperature.", "Other Information: Store at room temperature (do not freeze). Taper evident sealed packets. Do not use packet if opened or torn.", "Other information Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree F (15-30 degree C)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets" ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever" ], "set_id": "a44e5837-62b5-4668-96fd-5aba8346925d", "id": "3a45ef1e-0890-4c9f-a8b7-f3ecc8730bfe", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredients ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient (in each tablet) Ibuprofen USP (NSAID*) 200mg *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Acetaminophen 325 mg", "Active Ingredient (in each tablet) Aspirin (NSAID * ) 325 mg *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive Ingredients Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine", "Inactive Ingredients cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients Cornstarch, polyethylene glycol, stearic acid, povidone", "Inactive Ingredients hypromellose, polyethylene glycol, propylene glycol, corn starch" ], "warnings": [ "Warnings Warning: For external use only.", "Warnings For external use only.", "Warnings For external use only", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed" ], "spl_product_data_elements": [ "Genuine First Aid Industrial First Aid ASPIRIN, ACETAMINOPHEN, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, BENZALKONIUM CHLORIDE, LIDOCAINE, BENZALKONIUM CHLORIDE Antiseptic BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE ALOE VERA LEAF CETYL ALCOHOL DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL POLYETHYLENE GLYCOLS PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;352 White NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOLS STEARIC ACID POVIDONE White AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOLS PROPYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions Adults and children 2 years of age and older clean affected area. apply a small amount of this product on the area 1 to 3 times daily. may be covered with a sterile bandage children under 2 years of age: consult a doctor", "Directions do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days condition clears up and occurs again within a few days", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear" ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week Do not use: in the eyes or apply over large areas of the body. longer than 1 week unless directed by a doctor. in large quantities, particularly over raw surfaces or blistered areas. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns. When using this product, avoid contact with the eyes.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "ASPIRIN 2 Tablets", "Aspirin 325 mg", "Non Aspirin", "Ibuprofen 200mg", "Genuine Triple Antibiotic", "Burn Cream", "Antiseptic Towelette", "GFA First Aid Kit", "GFA First Aid Kit" ] }, { "effective_time": "20140501", "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product, do not use more than directed." ], "questions": [ "Questions? 1-877-340-8824" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information save carton for full directions & warnings store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever" ], "set_id": "a46c55a6-3706-49fc-a008-c33c3951ec09", "id": "46c87e85-184e-456a-ab77-e4e8e44ea0c3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 2 caplets with water every 4 hrs
children under 12 yrs ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients honey, hydroxypropyl methylcellulose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, natural flavor, polydextrose, polyvinyl pyrrolidone, propylene glycol, starch, stearic acid, sucralose, talc, titanium dioxide, yellow iron oxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash, fever or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks DayQuil Nature Fusion Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine honey hypromelloses magnesium stearate maltodextrin medium-chain triglycerides cellulose, microcrystalline polydextrose propylene glycol stearic acid sucralose talc titanium dioxide ferric oxide yellow NF;triangle" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children under 12 yrs ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash, fever or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 40 Caplet Carton Same Powerful Symptom Relief as DayQuil Cold & Flu VICKS ® DayQuil ® Nature Fusion™ COLD & FLU Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr with Real Honey FREE OF Alcohol Gluten Non-Drowsy Headache, Fever, Sore Throat Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Cough 40 Caplets PRINCIPAL DISPLAY PANEL - 40 Caplet Carton" ], "purpose_table": [ "
Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20150610", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain Reliever Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Allergy Severe Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;518" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 to 6 hours do not take more than 8 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling present These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 15127-385-24 select brand ™ the lower price name brand DOES NOT CONTAIN PSEUDOEPHEDRINE SEE NEW WARNINGS INFORMATION Allergy SEVERE Pain Releiver Antihistamine Sore, Scratchy Throat - Acetaminophen Runny Nose/Sneezing Itchy, Watery Eyes - Diphenhydramine HCl *Compare to the Active Ingredients of Tylenol® Severe Allergy 24 CAPLETS May Cause Drowsiness *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Severe Allergy. 50844 REV0612C51808 Distributed by: SELECT BRAND® DISTRIBUTORS Pine Bluff, AR 71603 USA AC (870) 535-3635 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING Select Brand 44-518 Select Brand 44-518" ], "indications_and_usage": [ "Uses temporarily relieves: runny nose sneezing itching of the nose or throat and itchy, watery eyes due to hay fever headache minor aches and pains" ], "set_id": "a488a640-b9db-4854-9489-3a10b707234e", "id": "769d15b1-55a8-45b3-b554-b50b9fa30bfb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20130719", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have diabetes high blood pressure heart disease thyroid disease trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dose" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Maximum Strength Pseudoephedrine Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE TRIACETIN 44;112" ], "ask_doctor": [ "Ask a doctor before use if you have diabetes high blood pressure heart disease thyroid disease trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel select brand® the lower price name brand NON-DROWSY NDC 15127-961-09 Maximum Strength PSEUDOEPHEDRINE PSEUDOEPHEDRINE HYDROCHLORIDE 30 MG NASAL DECONGESTANT • Nasal & Sinus Congestion • Cold Congestion • Allergy Congestion *Compare to the Active Ingredient of SUDAFED® SAFETY SEALED 24 TABLETS TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0310A11208 Distributed by: SELECT BRAND® DISTRIBUTORS Pine Bluff, AR 71603 USA AC (870) 535-3635 Product Packaging Product Packaging" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "a530f518-cfa9-4d61-ab46-a7567623cfce", "id": "b6c9f447-8550-4239-a00a-8f98101d3542", "active_ingredient": [ "Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years do not use this product in children under 6 years of age
" ] }, { "effective_time": "20100219", "inactive_ingredient": [ "OTHER INFORMATION Other information store at 15 – 30°C (59-86°F). Inactive ingredients Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide." ], "purpose": [ "PURPOSE Pain reliever/fever reducer USES temporarily relieves minor aches and pains due to: headache muscular aches minor pain or arthritis toothache backache the common cold menstrual cramps temporarily reduces fever" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center 1-800-362-0101 (Arizona only) immediately." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed" ], "when_using": [ "WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs long term continuous use ay increase the risk of heart attack or stroke" ], "questions": [ "QUESTIONS OR COMMENTS Call 1-800-262-5244 Monday though Friday 9AM – 2PM MST Distributed by: RejuviLife, Phoenix, AZ RejuviLife is a trademark of Apotheca Inc." ], "spl_product_data_elements": [ "IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE HYPROMELLOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE BROWN CAPSULE-SHAPE IP;142" ], "ask_doctor": [ "ASK DOCTOR Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers bleeding problems high blood pressure heart or kidney disease taken a diuretic reached age 60 or older Ask a doctor before use if you are taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition taking any other drug consuming 3 or more alcohol drinks per day" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DIRECTIONS d o not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in a 24-hour period, unless directed by a physician take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use consult a physician if these symptoms are more thsn mild or if they persist Children under 12 years not for use" ], "pregnancy_or_breast_feeding": [ "IF PREGNANT OR BREAST-FEEDING - ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "STOP USE AND ASK A DOCTOR IF you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "DO NOT USE if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST NDC 12634-860-01 IBUPROFEN MAXIMUM STRENGTH WITHOUT A PRESCRIPTION Pain Reliever Fever Reducer RejuviLife ® 100 CAPLETS 200 MG image of label" ], "set_id": "a6e57acd-b02a-472e-9cc6-8d4aea246164", "id": "6e315790-ef94-4772-8e76-2565f8b097d4", "active_ingredient": [ "ACTIVE INGREDIENT (in each Tablet) Ibuprofen 200 mg (NSAID)** **nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in a 24-hour period, unless directed by a physician take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years not for use
" ] }, { "effective_time": "20150417", "inactive_ingredient": [ "Inactive Ingredients colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, carnuba wax, lactose, polydextrose, polyethylene glycol" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery Ask a doctor before use if ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma ■ you are taking a diuretic Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke" ], "questions": [ "Questions or Comments? Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST." ], "spl_product_data_elements": [ "Dragon Tabs Ibuprofen 200 mg IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN HYPROMELLOSES FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN TITANIUM DIOXIDE LACTOSE POLYDEXTROSE POLYETHYLENE GLYCOLS 44291" ], "ask_doctor": [ "Ask a doctor before use if ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma ■ you are taking a diuretic" ], "other_safety_information": [ "Other information store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if seal under bottle cap is broken or missing." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions ■ do not take more than directed ■ the smallest effective dose should be used ■ do not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children 12 years and older: ■ take 1 tablet every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours unless directed by a doctor Children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding. pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Dragon Tabs Ibuprofen 200 mg/Ibuprofeno 200mg Pain Reliever/Fever Reducer (NSAID) Alivia el Dolor/Reduce la fiebre (AINE) Temporarily Relieves: Backache Muscular aches Alivio Temporal de: Dolor de Espalda Dolores Musculares 40 Tablets/Tabletas Z:\\SPL-OTC Mono\\Genomma\\Dragon\\Dragon Box.jpg" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache ■ backache ■ the common cold ■ menstrual cramps ■ temporarily reduces fever" ], "set_id": "ab07e341-51a3-4d8d-b584-0719da994c1c", "id": "ab07e341-51a3-4d8d-b584-0719da994c1c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor’s care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient Ibuprofen USP, 200mg (NSAID)** **nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120206", "inactive_ingredient": [ "Inactive ingredients Dicalcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Methacrylic Acid Copolymers, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Silica, Sodium Bicarbonate, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Talc, Titanium Dioxide, Triethyl Citrate" ], "purpose": [ "Purpose Stimulant laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age if your can't swallow without chewing for a period longer than 1 week, unless directed by a doctor" ], "questions": [ "Other Information each single maximum dose contains: calcium, 30 mg avoid excessive humidity store at temperatures not above 86 degrees F (30 C) Questions or Comments: 1-800-926-5222 M-F from 9-5 ET" ], "spl_product_data_elements": [ "Carters Little Pills Sodium-Free Bisacodyl BISACODYL BISACODYL DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSES MAGNESIUM STEARATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE SODIUM BICARBONATE SODIUM LAURYL SULFATE SODIUM GLYCOLATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE C" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea, or vomiting a sudden change in bowel habits that persists over 2 weeks When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablets you may have stomach discomfort, faintness and cramps" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Follow dosage below or use a directed by a doctor adults and children 12 years of age and over 1 to 3 tablets (usually 2) in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age consult a doctor" ], "stop_use": [ "Stop use and ask a doctor if you need to use a laxative for more than 1 week you fail to have a bowel movement or have rectal bleeding. These could be signs of a serious condition." ], "package_label_principal_display_panel": [ "Principal Display Overnight Relief Guaranteed CARTERS LITTLE PILLS Carter's BISACODYL DELAYED-RELEASED TABLETS STIMULANT LAXATIVE Sodium-Free ENTERIC COATED 25 TABLETS Carton image Carton image" ], "indications_and_usage": [ "Uses for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours" ], "set_id": "ab51f0ca-8c06-4fe3-a61d-0857e22a5315", "id": "3f7ff453-643d-4bc2-88a2-0a7979d6cc1a", "active_ingredient": [ "Active Ingredient (in each tablet) Bisacodyl USP, 5 mg" ] }, { "effective_time": "20100407", "inactive_ingredient": [ "Other information and inactive ingredients Other information store between 20° to 25°C (68° to 77°F) Inactive ingredients anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin" ], "purpose": [ "PURPOSE ANTIHISTAMINE 24 Hour Relief of Indoor and Outdoor Allergies USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat", "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away." ], "warnings": [ "WARNINGS Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "when_using": [ "When using this product drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary." ], "questions": [ "Questions Call 1-800-262-5244 Monday though Friday 9AM – 2PM MST Distributed by: RejuviLife, Phoenix, AZ RejuviLife is a trademark of Apotheca Inc." ], "spl_product_data_elements": [ "CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE HYPROMELLOSE TITANIUM DIOXIDE WHITE Barrel Shaped M;C37" ], "ask_doctor": [ "Ask a Doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. Adults 65 years and over Ask a doctor Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "package_label_principal_display_panel": [ "PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL NDC 12634-987-71 CETIRIZINE HCI Antihistamine Indoor and Outdoor Allergies 24 Hour Relief of Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose. Allergy Tablets RejuviLife 30 Tablets 10 MG image of label" ], "set_id": "abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f", "id": "4ff5ce14-77ce-4757-a40e-e7099f15a011", "ask_doctor_or_pharmacist": [ "Ask a Doctor or Pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "ACTIVE INGREDIENT (in each Tablet) Cetirizine HCI 10mg" ], "dosage_and_administration_table": [ "
Adults and children 6 years and over one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours.
Adults 65 years and over Ask a doctor
Children under 6 years of age Ask a doctor
Consumers with liver or kidney disease Ask a doctor
" ] }, { "effective_time": "20151216", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, silica gel, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain reliever Diuretic Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? Call 1-888-309-9030" ], "spl_product_data_elements": [ "Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate ACETAMINOPHEN ACETAMINOPHEN PAMABROM BROMOTHEOPHYLLINE PYRILAMINE MALEATE PYRILAMINE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;369" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "14", "dosage_and_administration": [ "Directions do not take more than the recommended dose (see overdose warning) adults and children 12 years and older: take 2 caplets with water every 6 hours as needed do not exceed 8 caplets in a 24-hour period or as directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Principal Display Panel DG™ health Compare to active ingredients in Pamprin® Multi-Symptom* Maximum Strength • Multi-Symptom Menstrual Pain Relief Acetaminophen Pamabrom • Pyrilamine maleate Pain Reliever/Diuretic/Antihistamine • Relieves cramps, bloating, irritability, headache & backache • Aspirin free • Caffeine free 32 Caplets *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Pamprin® Multi-Symptom. 50844 REV1013G36927 DISTRIBUTED BY DOLGENCORP, LLC 100 MISSIONS RIDGE GOODLETTSVILLE, TN 37072 100% Quality Guaranteed (888)309-9030 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Dollar General 44-369 Dollar General 44-369" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms associated with menstrual periods: cramps headaches bloating backaches water-weight gain irritability muscular aches" ], "set_id": "aca13ecf-8d94-41f7-a9e0-bc6676792156", "id": "2a8d9e37-4906-4e08-9152-ea442e87c488", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg" ] }, { "effective_time": "20130520", "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, corn starch, FD&C red #40 aluminum lake, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "questions": [ "Questions or comments? 1-855-STJOE81 (1-855-785-6381)" ], "spl_product_data_elements": [ "Adult Low Strength Aspirin Aspirin ASPIRIN ASPIRIN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS DIMETHICONE SODIUM ALGINATE SODIUM BICARBONATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE SJ" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better and allergic reaction occurs new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºF (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any pain reliever or fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 76000-414-32 Doctor Recommended 81mg Dose ST. JOSEPH® SAFETY COATED* ASPIRIN PAIN RELIEVER (NSAID) 81mg ASPIRIN REGIMEN 120 TABLETS 81mg each *Coating Helps Protect Against Stomach Upset Talk to your doctor before starting an aspirin regimen Aspirin is not right for everyone. Dist. by: St. Josephs Health Products, LLC Baltimore, MD 21201 St. Joseph 44-414SJ St. Joseph 44-414SJ" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "b3225815-1285-4500-8101-9a9a42ca7734", "id": "1ce9d337-cf7f-44ec-8edd-863260110482", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal silicon dixoide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age in persons who cannot swallow without chewing Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps" ], "spl_product_data_elements": [ "Womens Laxative Bisacodyl BISACODYL BISACODYL ACACIA FERROSOFERRIC OXIDE CALCIUM CARBONATE CARNAUBA WAX D&C RED NO. 27 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate POVIDONES PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;326" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not chew or crush tablets do not take within 1 hour after taking an antacid or milk adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) protect from excessive moisture see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use in children under 6 years of age in persons who cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Gentle, More Natural Overnight Relief Compare to the Active Ingredient of Correctol®* Our Family® Quality care since 1904 Women's Laxative GENTLE FORMULA Bisacodyl 5 mg enteric coated 30 TABLETS *This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Correctol®. 50844 REV0412E32601 DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Our Family 44-326 Our Family 44-326" ], "indications_and_usage": [ "Uses for gentle, overnight relief of occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "b5ae8018-952d-4fb3-8f8f-bd4e967bd405", "id": "9b444816-513a-4084-92ee-4e58cfd178cc", "active_ingredient": [ "Active ingredient (in each enteric coated tablet) Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose
children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20110801", "purpose": [ "Purpose Antiseptic", "Purpose Triple Antibiotic", "Purpose Pain reliever/fever reducer", "Purpose Antihistamine", "Purpose Pain reliever/fever reducer", "Purpose Pain reliever/fever reducer", "Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of the reach of children . In case of overdose, contact a physician or poison control center immediately.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs", "When Using This Product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children", "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature." ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever.", "Uses Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.", "Uses Temporarily relieves minor aches and pains associated with ■ headache ■ backache ■ common cold ■ minor arthritis pain ■ toothache ■ menstrual cramps ■ muscular aches Temporarily reduces fever.", "Uses For the temporary relief of minor aches and pains associated with headache common cold muscular aches toothache minor arthritis pain menstrual cramps For the reduction of fever." ], "set_id": "c3385112-669d-4175-b060-16c97b9955c1", "id": "e43e0834-b324-44ab-8881-9afb52fcf0af", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug", "Ask a doctor or pharmacist before use if you are taking any drugs for asthma taking sedatives or tranquilizers", "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug", "Active ingredients (in each capsule) Diphenhydramine Hydrochloride 25 mg", "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug", "Active ingredient (in each tablet) Acetaminophen 325 mg", "Povidone-iodine 10%" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive ingredients croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide* * may contain", "Inactive ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, starch", "Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain", "Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid * may contain" ], "warnings": [ "Warnings Warning: For external use only.", "Warnings For external use only.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Warnings Do not use with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking any drugs for asthma taking sedatives or tranquilizers When Using This Product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast feeding, ask a health professional before use. Keep out of the reach of children . In case of overdose, contact a physician or poison control center immediately.", "Warnings", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "spl_product_data_elements": [ "Mountain Series Weekender Medical BENZALKONIUM CHLORIDE, POVIDONE-IODINE, ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER MEDIQUE Aspirin Aspirin ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN ROUND 44;157;aspirin white Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN STARCH, CORN pink white CAPSULE CPC;835 MEDI-FIRST Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN white ROUND 44;352 MEDIQUE APAP Acetaminophen ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID white ROUND AZ;234 Aplicare Povidone-Iodine Solution Povidone-Iodine Solution POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC SODIUM HYDROXIDE NONOXYNOL-9 WATER" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic", "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "warnings_and_cautions": [ "Warnings Do not use if allergic to iodine in the eyes For external use only Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions do not use more than directed Adults and children: (12 years and older): Take 1 to 2 capsules every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours. Children under 12 years: Do not give to children under 12 years of age.", "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )", "Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age. Other information store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur", "Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301", "Other information read all product information before using store at room temperature 59º-86ºF (15º-30ºC) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets", "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets", "Allergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away.", "Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed", "Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.", "Children under 12 years: Do not give to children under 12 years of age.", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis", "Do not use with any other product containing diphenhydramine, even one that is used on skin.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor" ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "116R Medique APAP 325 mg Label Medique® Aspirin 5 Grain (325 mg) Pain Reliever/Fever Reducer (NSAID) See new warnings information East To Swallow Film Coated Tablets 24 Tablets (12 x 2) Compare active ingredients to Bayer® Registered Trademark Bayer Consumer Tamper Evident Unit Dose Packets", "182R Medique Diphen Label Collect Medi-Bucks See inside flap for more details Medique® Diphen Diphenhydramine HCl 25 mg Hay Fever/Allergies Fiebre del Heno/Alergias Pull to Open TiraParaAbrir Easy To Swallow Capsules Capsulas Faciles de Tragar 200 Capsules (200 x 1) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Untarias", "Principal Display Panel Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 100 tablets (50 x 2) Compare active ingredient to: Genuine Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets", "Principal Display Panel", "145R Medique APAP 325 mg Label Collect MediBucks See inside flap for more details Medique ® APAP Acetaminophen 325 mg Pain Reliever/Fever Reducer Alivia el Dolor/Reduce la Fiebre Easy To Swallow Film Coated Tablets Facil de Tragar Tabletas con Cubierta Pelicular Pull to Open Tire Para Abrir See new warnings information 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias", "Weekender Kit Label Mountain Series Medical Kit Weekender Adventure Medical Kits BE SAFE 1-6 People up to 7 days", "Povidone Iodine Solution", "Medique APAP", "Medique Ibuprofen", "Medique Aspirin", "Medique Diphenhydramine", "AntisepticTowelette", "GenuineTripleAntibiotic", "Weekender Kit", "Weekender Kit" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinnks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any of drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE 44;393" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "storage_and_handling": [ "Other information store between 20º-25ºC (68º-77ºF) avoid excess heat 40ºC (104ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel SAFETY SEALED Medicines for Body Aches and Pains Compare to the Active Ingredient of Motrin® IB Caplets† Our Family® Quality Care Since 1904 Ibuprofen TABLETS USP (NSAID) , 200 mg Pain Reliever / Fever Reducer 50 TABLETS** **Caplets (Capsule-Shaped Tablets) †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Motrin® IB Caplets. 50844 REV0411E39315 DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS, 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF16298 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Our Family 44-393 Our Family 44-393" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothecahe backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "c52a3a8a-bbcd-4bdd-91b1-07446db7a950", "id": "0cc55f8e-cfc8-45d9-ba4e-d4e610f98e86", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any of drug" ], "active_ingredient": [ "Active ingredient (in each orange caplet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20141209", "inactive_ingredient": [ "Inactive ingredients carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin* *may contain" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives skin reddening asthma (wheezing) facial swelling rash shock blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or longer than directed" ], "questions": [ "Questions or comments? 1-800-869-6970" ], "spl_product_data_elements": [ "Green Guard Ibupro Relief Ibuprofen CARNAUBA WAX CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONE SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE IBUPROFEN IBUPROFEN brown ROUND IP;140" ], "ask_doctor": [ "Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "100R Green Guard Ibuprofen Label Ibupro relief Compare active ingredient to Advil ® Green Guard ® Pull Out Ibuprofen 200 mg/Ibuprofeno 200 mg Pain Reliever/Fever Reducer (NSAID) Alivia el Dolor/ Reduce la Fiebre (AINE) Advil ® is a Registered Trademark of Pfizer Consumer Healthcare 125 packets of 2 Tablets 250 Tablets Order# 2251 Distributed by Green Guard ® St. Louis, MO 63045 100R Green Guard Ibuprofen Label" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain Temporarily reduces fever." ], "set_id": "c5f1c509-1c15-4269-8027-d49ba59dd107", "id": "09cc5c22-4a1c-504e-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110413", "purpose": [ "Purpose Antiseptic", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Purpose Triple Antibiotic", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product: take with food or milk if stomach upset occurs" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Flammable - keep away from fire or flame.", "Other information: Store at room temperature.", "Store at 59-86 degree F (15-30 degree C)", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets" ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns" ], "set_id": "c66d2fe6-8ea3-43ac-b6eb-b069641e781c", "id": "434e6dde-b242-4b12-b9ee-a8477063bf60", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin." ], "warnings": [ "Warnings Warning: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings For external use only.", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed" ], "spl_product_data_elements": [ "Easy Care First Aid Kit - Sports and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352" ], "ask_doctor": [ "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear" ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery." ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "Genuine Triple Antibiotic", "Non Aspirin", "Anitseptic Towelette", "Insect Sting Relief Pad", "Ibuprofen 200mg", "On The Go First Aid" ] }, { "effective_time": "20151210", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age in persons who cannot swallow without chewing Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Womens Laxative Bisacodyl BISACODYL BISACODYL ACACIA FERROSOFERRIC OXIDE CALCIUM CARBONATE CARNAUBA WAX D&C RED NO. 27 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate POVIDONES PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;326" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not chew or crush tablets do not take within 1 hour after taking an antacid or milk adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) protect from excessive moisture see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use in children under 6 years of age in persons who cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Correctol ® active ingredient* NDC 37808-326-11 H-E-B ® WOMEN'S LAXATIVE Bisacodyl, 5mg Stimulant Laxative Gentle, Dependable, Overnight Relief 60 Tablets *This product is not manufactured or distributed by MSD Consumer Care, Inc.,, owner of the registered trademark Correctol ® . 50844 REV0412B32611 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING HEB 44-326 HEB 44-326" ], "indications_and_usage": [ "Uses for gentle, overnight relief of occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "c69a4b08-59f5-42dc-8a0f-71fe409ffd3e", "id": "6480719e-db0b-42e5-bc3f-874b23c28fea", "active_ingredient": [ "Active ingredients Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose
children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20111020", "inactive_ingredient": [ "I nactive Ingredients povidone, stearic acid, sodium croscarmellose, hydroxypropylmethylcellulose, titanium dioxide, polydextrose, triacetin, polyethylene glycol, DC Yellow No.10" ], "purpose": [ "Purpose Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "warnings": [ "Warning: Do not use: •with any other product containing acetaminophen •for more than 10 days for pain, unless directed by a doctor •for more than 3 days for fever, unless directed by a doctor" ], "spl_product_data_elements": [ "XL-DOL acetaminophen ACETAMINOPHEN ACETAMINOPHEN POVIDONE STEARIC ACID CROSCARMELLOSE SODIUM HYPROMELLOSES TITANIUM DIOXIDE POLYDEXTROSE TRIACETIN POLYETHYLENE GLYCOLS D&C YELLOW NO. 10 light yellow Tablet XL;DOL" ], "ask_doctor": [ "Stop using the product and ask a doctor if •symptoms do not improve •new symptoms occur •pain or fever persist or gets worse •redness or swelling is present" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and over: take 1 to 2 tablets every 4 to 6 hours as needed, do not take more than 8 tablets in 24 hours unless directed by a doctor, for children under 12 years of age consult a doctor." ], "spl_unclassified_section": [ "Alcohol Warning : If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage." ], "package_label_principal_display_panel": [ "Package Label image of package label" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains associated with: •common cold •headaches •toothache •muscular aches •minor pain from arthritis •reduce fever" ], "set_id": "c6b28c7d-a649-43d5-bd93-a7364c509d11", "id": "132086cf-8509-4e69-b2f7-4a3e1f462a09", "active_ingredient": [ "Active Ingredients (in each tablet) Acetaminophen USP 500 mg" ] }, { "effective_time": "20150504", "inactive_ingredient": [ "The mixed powder containing Lemon balm extract: ((Lemon balm extract(Switzerland), and Mulberry leaf extract(Korea)), Chicory root extract powder(Chile), Microcrystalline cellulose, Polydextrose, Hydroxypropylmethyl cellulose, Magnesium stearate, Stearic acid, Silicon Dioxide, Dry yeast(Se 0.1%), Zinc oxide, Dry yeast (Cr 0.2%), Nicotinamide, Glycerin esters of fatty acids, Pyridoxine Hydrochloride, Thiamine Hydrochloride, Riboflavin, Cyanocobalamin" ], "purpose": [ "for body fat loss" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "1. Stop intake if an allergic reaction occurs. 2. Children and pregnant or lactating women should be careful in intake." ], "spl_product_data_elements": [ "OB-X CALCIUM PANTOTHENATE CALCIUM PANTOTHENATE PANTOTHENIC ACID MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID angio tablet 3;hp;x" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "for oral use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "take 1 tablet twice daily with plenty of water" ], "set_id": "c8b941b8-7fb0-4d17-b0c2-65d948cbc0ca", "id": "4781138a-93df-43a2-a45c-26aa650fe17f", "active_ingredient": [ "CALCIUM PANTOTHENATE" ] }, { "effective_time": "20121016", "inactive_ingredient": [ "Inactive ingredients carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide. Questions or comments? Call 1-800-540-3765" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock hives facial swelling asthma (wheezing) skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present in the painful area fever gets worse or lasts more than 3 days any new symptoms occur If pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-540-3765" ], "spl_product_data_elements": [ "Ibuprofen ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX STARCH, CORN SILICON DIOXIDE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS FERRIC OXIDE RED STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE 44291" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not take more than 6 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor" ], "storage_and_handling": [ "Other information store at controlled room temperature avoid excessive heat 40°C (104°F)" ], "package_label_principal_display_panel": [ "Package label SEE NEW WARNINGS IBUPROFEN pain reliever/fever reducer (NSAID) COMPARE TO THE ACTIVE INGREDIENT IN ADVIL* 100 Tablets 200 mg each Tamper Evident: Do not use if imprinted seal under cap is missing or broken. Ibuprofen 200mg" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis Temporarily reduces fever" ], "set_id": "c9d22362-e442-4690-9aa9-9d34aef09504", "id": "c9d22362-e442-4690-9aa9-9d34aef09504", "active_ingredient": [ "Active ingredient (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20140825", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin" ], "purpose": [ "Purpose Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed recommended dose." ], "questions": [ "Questions or comments? (800) 616-2471" ], "spl_product_data_elements": [ "SudoGest Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE TRIACETIN 44;112" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever" ], "spl_unclassified_section": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "SUDOGEST (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED Label Image" ], "indications_and_usage": [ "Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure" ], "set_id": "cbd9f197-b0aa-4f23-a608-cd85e9a35dc0", "id": "3cfa4423-544d-4631-8d2b-d0ce1e8b8d3c", "active_ingredient": [ "Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and older take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 years do not use this product in children under 6 years of age
" ] }, { "effective_time": "20150409", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, FD&C blue no. 2 lake, fractionated coconut oil, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, silicon dioxide, starch, stearic acid, talc titanium dioxide" ], "purpose": [ "Purpose Nighttime sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid. When using this product, avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "when_using": [ "When using this product, avoid alcoholic drinks." ], "questions": [ "Questions or comments? Call 1-877-869-3304" ], "spl_product_data_elements": [ "Somnapure Clinical Strength Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C BLUE NO. 1 FD&C BLUE NO. 2 medium-chain triglycerides HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE SILICON DIOXIDE STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE SPCS" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland" ], "other_safety_information": [ "Other information store at 15°-30°C (59°-86°F)" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and older: 1 caplet (50 mg) at bedtime if needed, or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness." ], "do_not_use": [ "Do not use in children under 12 years of age with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Peak Life Somnapure® Clinical Strength Nighttime Sleep Aid / Diphenhydramine HCL Fall Asleep Quickly Wake Up Energized Non-Habit-Forming #1 Doctor-Recommended Ingredient 30 Sleep Caplets One Caplet per Dose Distributed by Peak Life, LLC, a subsidiary of NutraClick, LLC PeakLife.com / 1-877-869-3304 Boston, MA 02108 Outer Label Inner Box Label" ], "indications_and_usage": [ "Use for relief of occasional sleeplessness" ], "set_id": "cddfdbdd-e6d0-49ef-88e7-b5827c665140", "id": "07dcc7b4-c6c4-4d66-b84e-5eaf408acc84", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid." ], "active_ingredient": [ "Drug Facts Active ingredient (in each caplet) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20151116", "inactive_ingredient": [ "Inactive ingredients black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "spl_product_data_elements": [ "Aspirin Enteric Aspirin ASPIRIN ASPIRIN FERROSOFERRIC OXIDE SILICON DIOXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BICARBONATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;227" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "9", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information use by expiration date on package store at 25ºC (77ºF); excursion permitted between 15º-30ºC (59º-86ºF)" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer." ], "package_label_principal_display_panel": [ "Principal Display Panel CVS pharmacy® Compare to the active ingredient in Ecotrin ®† ENTERIC ASPIRIN 325 mg PAIN RELIEVER (NSAID) • Safety coated • Aspirin regimen • Regular strength 500 TABLETS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin ® . 50844 ORG111322714 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2014 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-11112 √ CVS Quality Money Back Guarantee CVS 44-227 CVS 44-227" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains due to: colds toothache muscle pain menstrual pain headache minor pain of arthritis or as recommended by a doctor" ], "set_id": "cf30f244-654f-b641-1fac-9e5bbbdb17f8", "id": "c14ffa7d-0734-42fa-8aa9-4b32eaffac9e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100806", "purpose": [ "PURPOSE Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? call 1-800-426-9391" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "OTHER INFORMATION store at controlled room temperature avoid excessive heat above 40°C (104°F) see end flap or expiration date and lot number" ], "indications_and_usage": [ "USES temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "d00bbec7-d507-b571-4e16-5c72f726ab87", "id": "4a0deb5d-8961-c8c8-2274-eb622422f259", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "ACTIVE INGREDIENT (in each orange caplet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS carnauba wax, cellulose, corn starch, FD&C yellow #6, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodiumstarch glycolate, stearic acid, titanium dioxide Questions or comments? call 1-800-426-9391", "carnauba wax, cellulose, corn starch, FD&C yellow #6, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodiumstarch glycolate, stearic acid, titanium dioxide" ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing perscription or nonperscription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:. feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Ibuprofen ibuprofen Ibuprofen Ibuprofen Carnauba Wax Powdered Cellulose Starch, Corn Fd&c Yellow No. 6 Hypromellose Lactose Magnesium Stearate Polydextrose Polyethylene Glycol Stearic Acid Titanium Dioxide 44;392 Product Label" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see WARNINGS ) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "DRUG FACTS" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:. feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. DG health Compare to active ingredient of Motrin® IB† Ibuprofen Tablets 200 mg Pain Reliever/Fever Refucer (NSAID) SEE NEW WARNINGS INFORMATION 100 Coated Tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV1209B39212 DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072" ] }, { "effective_time": "20100607", "inactive_ingredient": [ "Inactive Ingredient: Purified water", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch" ], "purpose": [ "Purpose: First aid antiseptic, external analgesic Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only", "Warning: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed" ], "when_using": [ "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor" ], "spl_product_data_elements": [ "Auto 157 BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSE LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352 NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSE POLYETHYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN" ], "description": [ "LOT/EXP: Made in CHINA 20130301", "LOT/EXP: Made in CHINA 20130301", "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "Directions: Clean affected area, Apply small amount not more than 3 times daily. May be covered with a sterile bandage.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear" ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other Information: Store at room temperature", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree Fahrenheit (15-30 degree Celcius)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets" ], "do_not_use": [ "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week", "Do not use in the eyes or over large areas of the body.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis" ], "package_label_principal_display_panel": [ "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "BurnCream", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "IBUPROFEN 2 Tablets", "Ibuprofen", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "Non Aspirin", "ASPIRIN 2 Tablets", "Aspirin 325 mg", "CARRYING CASE 1 Hard Case 1 Easy Access Pocket System POCKET 1: SMALL CUTS and BURNS 50 Adhesive Plastic Bandages 3/4\" X 3\" 40 Junior Adhesive Plastic Bandages 3/8\" X 1-1/2\" 2 Knuckle Fabric Bandages 1 Adhesive Spot Bandages 7/8\"X7/8\" 1 Fingertip Fabric Bandage 3 Burn Cream 12 Antiseptic Towelettes 10 Cotton Tipped Applicators POCKET 2: MEDIUM CUTS and SCRATCHES 6 Sterile Gauze Pads 2\"X2\" 2 Sterile Gauze Pads 3\"X3\" 1 Roller Gauze Bandage 2\" X 4.1yds. POCKET 3: SEVERE BLEEDING and BURNS 1 First Aid Tape Roll 1/2\" X 5yds. 1 Combine Pad 5\" X 9\" POCKET 4: CPR 1 CPR Breathing Barrier POCKET 5: PROTECTION 2 Medical Grade Vinyl Gloves 1 Instant Cold Compress 1 Emergency Blanket 38\" X 60\" 2 Insect Sting Relief Pads 1 Triangular Bandage 42\" X 42\" X 59\" 4 Ibuprofen 200mg 4 Non Aspirin 325mg 2 Aspirin 325mg POCKET 6: INSTRUMENTS 1 Emergency First Aid Guide 2 Assorted Safety Pins ------------------------------------------------------------------------- ESTUCHE PORTATIL 1 Estuche de Plastico 1 Sistema de fundas para rapido acceso FUNDA 1: CORTADURAS Y QUEMADURAS MENORES 50 Vendas Adhesivas Plasticas 3/4\" X 3\" 40 Vendas Plasticas Tamano Junior 3/8\" X 1-1/2\" 2 Vendas de Tela para Nudillos 5 Vendas Adhesivas Redondas 7/8\"X7/8\" 1 Vendas de tela para yema del dedo 3 Cream para Quemaduras 12 Toallitas Antisepticas 10 Aplicadores con Puntas de Algodon FUNDA 2: CORTADURAS Y RASGUNOS MEDIANOS 6 Almohadillas Esteril de Gasa 2\"X2\" 2 Almohadillas Esteril de Gasa 3\"X3\" 1 Vendas de Gasa en Rollo 2\" X 4.1yds. FUNDA 3: SANGRADO SEVERO Y QUEMADURAS 1 Cinta de papel para Primeros Auxilios 1/2\" X 5yds. 1 Almohadilla de Uso Combinado 5\" X 9\" FUNDA 4: CPR 1 Mascarilla CPR FUNDA 5: PROTECCION 2 Guantes de Vinilo 1 Compresa de Frio Instantaneo 1 Manta Termica 38\" X 60\" 2 Toallitas para Picaduras de Insectos 1 Vendajes Triangulares 42\" X 42\" X 59\" 4 Ibuprofen 200mg 4 Non Aspirin 325mg 2 Aspirin 325mg 325mg FUNDA 6: INSTRUMENTOS 1 Manual de Primeros Auxilios 2 Imperdibles ( alfileres de gancho ) Genuine First Aid LLC 814471010167 Copyright c 2010 Genuine First Aid LLC. All rights reserved. Manufactured in China for: Genuine First Aid LLC. 600 Cleveland Street Suite 400 Clearwater, FL 33755 www.GenuineFirstAid.com GENUINE FIRST AID.", "Auto Kit157 Label" ], "set_id": "d0d44c0f-e435-473f-93a4-71a79c6bc04a", "id": "91aa1891-7ebd-49e8-b874-e0b550b09bd6", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID*) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120921", "inactive_ingredient": [ "Inactive ingredients black iron oxide, corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, mtehacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, propylene glycol, shellac wax, silca, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if you experienece any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-426-9391 weekdays" ], "spl_product_data_elements": [ "81 mg Low Dose Aspirin Aspirin ASPIRIN ASPIRIN STARCH, CORN D&C YELLOW NO. 10 HYPROMELLOSES METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS PROPYLENE GLYCOL SHELLAC SODIUM BICARBONATE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE L" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experienece any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. new symptoms occur ringing in the ears or loss of hearing occurs pain gets worse or lasts more than 10 days redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel 120 tablets SEE NEW WARNINGS INFORMATION SOUND BODY ™ 81 MG LOW DOSE ASPIRIN ENTERIC COATED ASPIRIN 81 mg (NSAID) COMPARE TO THE ACTIVE INGREDIENT OF BAYER ® LOW DOSE 81 MG ASPIRIN† 120 tablets †This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin. 50844 ORG041160032 Manufactured by: LNK International, Inc. Hauppauge, NY 11788 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING SoundBody 44-600 SoundBody 44-600" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains or as recommended by your doctor" ], "set_id": "d96154e4-c72e-454c-9e1f-14e7a880bde2", "id": "4cec0e43-287b-4136-9070-ebf154eddf49", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110801", "purpose": [ "Purpose Antiseptic", "Purpose Triple Antibiotic", "Purpose Pain reliever/fever reducer", "Purpose Antihistamine", "Purpose Pain reliever/fever reducer", "Purpose Pain reliever/fever reducer", "Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of the reach of children . In case of overdose, contact a physician or poison control center immediately.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs", "When Using This Product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children", "When using this product take with food or milk if stomach upset occurs" ], "questions": [ "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680", "Questions or comments? 1-800-634-7680" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature." ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses Temporarily relieves minor aches and pains associated with headache minor arthritis common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever.", "Uses Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.", "Uses Temporarily relieves minor aches and pains associated with ■ headache ■ backache ■ common cold ■ minor arthritis pain ■ toothache ■ menstrual cramps ■ muscular aches Temporarily reduces fever.", "Uses For the temporary relief of minor aches and pains associated with headache common cold muscular aches toothache minor arthritis pain menstrual cramps For the reduction of fever." ], "set_id": "e4b05cbc-526e-4a03-a943-631a0feb6947", "id": "57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug", "Ask a doctor or pharmacist before use if you are taking any drugs for asthma taking sedatives or tranquilizers", "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active ingredient (in each tablet) Aspirin (NSAID*) 325 mg *nonsteroidal anti-inflammatory drug", "Active ingredients (in each capsule) Diphenhydramine Hydrochloride 25 mg", "Active ingredient (in each tablet) Ibuprofen (NSAID * ) 200 mg * nonsteroidal anti-inflammatory drug", "Active ingredient (in each tablet) Acetaminophen 325 mg", "Povidone-iodine 10%" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive ingredients croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide* * may contain", "Inactive ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, starch", "Inactive ingredients carnauba wax * , cellulose * , colloidal silicon dioxide, corn starch * , hypromellose, iron oxide red * , lactose, magnesium stearate, microcrystalline cellulose * , polydextrose, polyethylene glycol, povidone, silica * , sodium lauryl sulfate * , sodium starch glycolate, stearic acid * , titanium dioxide, triacetin * * may contain", "Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid * may contain" ], "warnings": [ "Warnings Warning: For external use only.", "Warnings For external use only.", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Warnings Do not use with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking any drugs for asthma taking sedatives or tranquilizers When Using This Product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast feeding, ask a health professional before use. Keep out of the reach of children . In case of overdose, contact a physician or poison control center immediately.", "Warnings", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "spl_product_data_elements": [ "Mountain Series Weekender Medical BENZALKONIUM CHLORIDE, POVIDONE-IODINE, ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER MEDIQUE Aspirin Aspirin ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN ROUND 44;157;aspirin white Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN STARCH, CORN pink white CAPSULE CPC;835 MEDI-FIRST Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN white ROUND 44;352 MEDIQUE APAP Acetaminophen ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSES POLYETHYLENE GLYCOL POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID white ROUND AZ;234 Aplicare Povidone-Iodine Solution Povidone-Iodine Solution POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC SODIUM HYDROXIDE NONOXYNOL-9 WATER" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic", "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "warnings_and_cautions": [ "Warnings Do not use if allergic to iodine in the eyes For external use only Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Avoid pooling beneath patient Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions do not use more than directed Adults and children: (12 years and older): Take 1 to 2 capsules every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours. Children under 12 years: Do not give to children under 12 years of age.", "Directions do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings )", "Directions do not use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age. Other information store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets" ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur", "Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301", "Other information read all product information before using store at room temperature 59º-86ºF (15º-30ºC) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets", "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets", "Allergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives asthma (wheezing) rash blisters skin reddening facial swelling shock If an allergic reaction occurs, stop use and seek medical help right away.", "Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed", "Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.", "Children under 12 years: Do not give to children under 12 years of age.", "Other information read all product information before using store at 68-77°F (20-25°C) avoid excessive heat 40°C (above 104°F) tamper evident sealed packets do not use any opened or torn packets" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery if you are taking prescription drugs for gout, diabetes or arthritis", "Do not use with any other product containing diphenhydramine, even one that is used on skin.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor" ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "116R Medique APAP 325 mg Label Medique® Aspirin 5 Grain (325 mg) Pain Reliever/Fever Reducer (NSAID) See new warnings information East To Swallow Film Coated Tablets 24 Tablets (12 x 2) Compare active ingredients to Bayer® Registered Trademark Bayer Consumer Tamper Evident Unit Dose Packets", "182R Medique Diphen Label Collect Medi-Bucks See inside flap for more details Medique® Diphen Diphenhydramine HCl 25 mg Hay Fever/Allergies Fiebre del Heno/Alergias Pull to Open TiraParaAbrir Easy To Swallow Capsules Capsulas Faciles de Tragar 200 Capsules (200 x 1) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Untarias", "Principal Display Panel Medi-First® Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Easy To Swallow Film Coated Tablets See new warnings information 100 tablets (50 x 2) Compare active ingredient to: Genuine Advil® Registered trademark Wyeth Consumer Tamper Evident Unit Dose Packets", "Principal Display Panel", "145R Medique APAP 325 mg Label Collect MediBucks See inside flap for more details Medique ® APAP Acetaminophen 325 mg Pain Reliever/Fever Reducer Alivia el Dolor/Reduce la Fiebre Easy To Swallow Film Coated Tablets Facil de Tragar Tabletas con Cubierta Pelicular Pull to Open Tire Para Abrir See new warnings information 500 Tablets (250 x 2) Tamper Evident Unit Dose Packets Empaquetado con Sellado Evidente en Dosis Unitarias", "Weekender Kit Label Mountain Series Medical Kit Weekender Adventure Medical Kits BE SAFE 1-6 People up to 7 days", "Povidone Iodine Solution", "Medique APAP", "Medique Ibuprofen", "Medique Aspirin", "Medique Diphenhydramine", "AntisepticTowelette", "GenuineTripleAntibiotic", "Weekender Kit", "Weekender Kit" ] }, { "effective_time": "20150505", "inactive_ingredient": [ "Other Ingredients May Contain: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Hydroxypropyl Cellulose (Modified Cellulose), Magnesium Stearate, Silicon Dioxide, Sodium Citrate Dihydrate, Ascorbic Acid, Citric Acid, L-Glutathione, Hydroxypropyl Methylcellulose (Modified Cellulose), Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Triglycerides, FD&C Blue #2, FD&C Red #40, FD&C Yellow #5, Polyethylene Glycol, Cellulose, Food Glaze, Micro Wax and other ancillary ingredients as needed to ensure product stability. CAUTION: Contains FD&C Blue #2, FD&C Red #40 and FD&C Yellow #5. Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality." ], "contraindications": [ "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated." ], "references": [ "REFERENCES: Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2. Federal Register Notice of April 9, 1971 (36 FR 6843). The Federal Register Notice of August 2, 1973 (38 FR 20750). The Federal Register Notice of October 17, 1980 (45 FR 69044). The Federal Register Notice of August 2, 1973 (38 FR 20750). Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000. The Federal Register Notice of March 5, 1996 (61 FR 8760). Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000. Code of Federal Regulations Title 21 Section 172.345. Code of Federal Regulations Title 21 Section 101.9(j)(8). Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7." ], "precautions": [ "PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress." ], "warnings": [ "WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study. 13 Patients undergoing cancer treatment should consult their licensed medical practitioner for advice." ], "pregnancy": [ "PREGNANCY and NURSING MOTHERS Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins. Talk with your medical practitioner before using Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) if pregnant or lactating." ], "spl_product_data_elements": [ "Levomefolate Calcium, Acetylcysteine, Mecobalamin and Algal levomefolate calcium, methylcobalamin, acetylcysteine and schizochytrium dha oil LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN ACETYLCYSTEINE ACETYLCYSTEINE SCHIZOCHYTRIUM DHA OIL SCHIZOCHYTRIUM DHA OIL CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STEARIC ACID HYDROXYPROPYL CELLULOSE (TYPE H) MAGNESIUM STEARATE SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE ASCORBIC ACID CITRIC ACID MONOHYDRATE GLUTATHIONE HYPROMELLOSES POLYDEXTROSE TITANIUM DIOXIDE TALC MALTODEXTRIN C10-18 TRIGLYCERIDES FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 5 POLYETHYLENE GLYCOLS POWDERED CELLULOSE SHELLAC MICROCRYSTALLINE WAX V324" ], "description": [ "DESCRIPTION: Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg)should be administered under the supervision of a licensed medical practitioner. Each coated, gray caplet contains the following dietary ingredients: Supplement Facts Serving Size: 1 caplet Servings Per Container: 90 Amount per Serving % Daily Value L-Methylfolate Calcium contains less than 1% d-methylfolate. 6.0 mg Daily Value not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner. Methylcobalamin 2.0 mg 33,333 N-Acetylcysteine 600 mg Algal Powder From algae derived from schizochytrium sp, ulkenia sp, and/or crypthecodinium cohnii strains 90.314 mg" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Usual adult dose is one caplet daily or as prescribed by a licensed medical practitioner. Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is not recommended for use in children under the age of twelve." ], "adverse_reactions": [ "ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine. Call your medical practitioner about side effects.", "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B 12 (Methylcobalamin). Nausea, vomiting, headache, other gastrointestinal symptoms, and rash (with or without mild fever) have been associated with N-acetylcysteine. There are rare reports of renal stone formation with N-acetylcysteine. If headaches occur with the use of this product, consult your medical practitioner." ], "spl_unclassified_section": [ "Caplets R x Prescription Dietary Supplement", "FOLATE MECHANISM OF ACTION: FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.", "FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood 4,5,6 . Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that \"The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added] 9,10\" . The actual amount and source of folate require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that \"dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated. When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added] 7 .\" However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (R x )-folate regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345) 11 . In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B 6 , and Vitamin B 12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote \"... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B 12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B 12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B 12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added] 8 .\" Summary: This product is a dietary management product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.", "ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.", "INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product .", "PHARMACOLOGY: FOLATE - Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. 3 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the \"methyl trap\" hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate 10 . Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate 10 .", "PATIENT INFORMATION: Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is a prescription dietary supplement to be used only under licensed medical supervision.", "DRUG INTERACTIONS: Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced serum folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folinic acid may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study. Drugs which may interact with vitamin B 12 (Methylcobalamin): Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B 12 . Nitrous oxide can produce a functional vitamin B 12 deficiency.", "KEEP THIS OUT OF THE REACH OF CHILDREN. R x Prescription Dietary Supplement All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.", "Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL 33619 www.virtusRX.com MADE IN USA Virtus PHARMACEUTICALS REV 4/2014" ], "storage_and_handling": [ "STORAGE: Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. Call your medical practitioner about side effects. You may report side effects by calling (813)-283-1344." ], "how_supplied": [ "HOW SUPPLIED: Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is supplied as a coated, gray caplet debossed \"V324\", dispensed in bottles of 90 caplets. NDC † 76439- 324 -90 † This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications. This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Virtus PHARMACEUTICALS NDC 76439- 324 -90 † Levomefolate Calcium * / Acetylcysteine/Mecobalamin/ Algal Powder (6 mg-600 mg-2 mg-90.314 mg) Prescription Vitamin B 9 -Containing Dietary Supplement R x 90 Tablets Made in the USA PRINCIPAL DISPLAY PANEL - 90 tablets" ], "indications_and_usage": [ "INDICATIONS AND USAGE: Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) is indicated for the distinct nutritional requirements of patients in need of advanced folate supplementation-specifically suboptimal folate or maintenance-level needs, as determined by a licensed medical practitioner. Levomefolate Calcium/Acetylcysteine/Mecobalamin/Algal Powder (6 mg-600 mg-2 mg-90.314 mg) should be administered under the supervision of a licensed medical practitioner." ], "set_id": "ebce1ffd-5df2-4e18-853b-95665e459a96", "id": "86bba0a7-bb05-4bd5-ad3b-210b87f707ab", "description_table": [ "
Supplement Facts
Serving Size: 1 caplet Servings Per Container: 90
Amount per Serving % Daily Value
L-Methylfolate Calcium contains less than 1% d-methylfolate. 6.0 mg Daily Value not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Methylcobalamin 2.0 mg 33,333
N-Acetylcysteine 600 mg
Algal Powder From algae derived from schizochytrium sp, ulkenia sp, and/or crypthecodinium cohnii strains 90.314 mg
" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn stach, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives shock facial swelling skin reddening asthma (wheezing) rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have 3 or more alcoholic drinks every day while using this product take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, iburpofen, naproxen, or others] have had stomach ulcers or bleeding problems take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday - Friday" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS STEARIC ACID TITANIUM DIOXIDE 44;292" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "storage_and_handling": [ "Other information store between 20º-25ºC (68º-77ºF) avoid excessive heat 40ºC (104ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel SAFETY SEALED Medicine for Body Aches and Pains Compare to the Active Ingredient of Advil®† Our Family® Quality Care Since 1904 Ibuprofen TABLETS USP, (NSAID) , 200 mg PAIN RELEIVER / FEVER REDUCER 100 CAPLETS** **Caplets (Capsule-Shaped Tablets) †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Caplets. 50844 REV0411E29212 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Our Family 44-292 Our Family 44-292" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "ec06a57e-e903-4e08-8b38-1b8128b28e69", "id": "2a5d9752-cad6-4ee8-9908-195d1bc7d82c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each brown tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120208", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions? To Report Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 44;291" ], "ask_doctor": [ "Ask a doctor before use if you have stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have problems or serious side effects from taking pain relievers or fever reducers" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "storage_and_handling": [ "Other information store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package" ], "do_not_use": [ "Do not use right before or after heart surgery if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. MAJOR® NDC 0904-7915-80 †Compare to the active ingredient in Advil® Tablets See New Warnings Information Ibuprofen Tablets Ibuprofen Tablets, USP 200 mg Pain Reliever Fever Reducer (NSAID) 1000 COATED TABLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAD UNDER CAP IS BROKEN OR MISSING 50844 REV0910B29116 Distributed by MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA M-17 Rev.11/10 Re-order No. 700643 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444 Product Packaging Product Packaging" ], "indications_and_usage": [ "Use(s) temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "ec219fae-1b21-405f-939d-992b7ccc38c1", "id": "6608c82e-6913-4928-b4fb-3815863ce2d0", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor\"s care for any serious condition" ], "active_ingredient": [ "Active ingredient(s) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin" ], "purpose": [ "Purpose Pain Reliever Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Severe Allergy Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;518" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 to 6 hours do not take more than 8 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling present These could be signs of a serious condition." ], "spl_unclassified_section": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDEDǂ NDC 0363-0518 SEVERE Allergy Acetaminophen 500 mg / Pain Reliever Diphenhydramine HCl 12.5 mg / Antihistamine • Relief of runny nose, sneezing, sore or scratchy throat & itchy, watery eyes 24 CAPLETS Compare to Tylenol® Severe Allergy Caplets active ingredientsǂǂ PSEUDOEPHEDRINE FREE TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING ǂWalgreens Pharmacist Survey Study, November 2010. ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Severe Allergy Caplets. 50844 ORG061251808 Walgreens 44-518 Walgreens 44-518" ], "indications_and_usage": [ "Uses temporarily relieves: runny nose sneezing itching of the nose or throat and itchy, watery eyes due to hay fever headache minor aches and pains" ], "set_id": "efa21438-0871-416f-88cc-60a0d76bf865", "id": "b4c5cb1e-f410-4c92-b9cb-e76efe28f66b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 12.5 mg" ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Ibuprofen maay cause a severe allergic reaction, especially in people allergy to aspirin. Sympoms may include: facial swelling rash hives asthma (wheezing) shock skin reddening blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days any new symptoms appear redness or swelling is present in the painful area fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE 44;392" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days any new symptoms appear redness or swelling is present in the painful area fever gets worse or lasts more than 3 days" ], "storage_and_handling": [ "Other information store between 20º-25ºC (68º-77ºF) avoid excessive heat 40ºC (104ºF) used by expiration date on package" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel Medicine for Body Aches and Pains Compare to the Active Ingredients of Motrin® IB Tablets† Our Family® Quality Care Since 1904 See New Warnings Information Ibuprofen Tablets USP (NSAID) , 200 mg Pain Reliever / Fever Reducer 50 TABLETS SAFETY SEALED †This product is not manufactured or distributed by McNeil Consumer Health, Inc, owner of the registered trademark Motrin® IB Tablets. DISTRIBUTED BY: NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF16388 50844 REV0411D39215 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Our Family 44-392 Our Family 44-392" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache toothache menstrual cramps the common cold backache muscular aches minor pain of arthritis temporarily reduces fever" ], "set_id": "f7c1d2bc-7199-4f29-a9d8-75a7cdea320a", "id": "e964bc7e-c786-454a-9523-74b3c770f4dd", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each tablet) Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20131112", "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST" ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if neck wrap or foil inner seal imprinted \"Safety Seal®\" is broken or missing see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches" ], "set_id": "f7ddef57-fb94-4b26-89c2-98cdfef88a0f", "id": "64da9650-7a6b-41bc-8b57-5c63cda1e5c2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug" ], "active_ingredient": [ "Active ingredient (in each caplet) Ibuprofen 100 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
Dosing Chart
Weight (lb) Age (yr) Caplets
under 48 under 6 ask a doctor
48-59 6-8 2
60-71 9-10 2 ½
72-95 11 3
" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, shellac, sodium starch glycolate, titanium dioxide, triacetin" ], "warnings": [ "Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Sore throat warning Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor. Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Motrin Junior Strength Ibuprofen Ibuprofen Ibuprofen acesulfame potassium carnauba wax silicon dioxide starch, corn D&C yellow NO. 10 aluminum oxide FD&C yellow NO. 6 hypromelloses cellulose, microcrystalline polydextrose polyethylene glycols shellac sodium starch glycolate type a potato titanium dioxide triacetin M;100" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, or kidney disease child has asthma child is taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions this product does not contain directions or complete warnings for adult use do not give more than directed find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Caplets under 48 under 6 ask a doctor 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding feels faint vomits blood has bloody or black stools has stomach pain that does not get better the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "do_not_use": [ "Do not use if the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL See New Warnings Information NDC 50580-498-24 Motrin ® Junior Strength For Ages 6 to 11 Lasts up to 8 hours contains Ibuprofen Tablets (NSAID), 100 mg Pain Reliever / Fever Reducer 24 Caplets* *Capsule-Shaped Tablets Principal Display Panel" ] }, { "effective_time": "20151111", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use in children under 6 years of age in persons who cannot swallow without chewing Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Laxative for Women Bisacodyl BISACODYL BISACODYL ACACIA FERROSOFERRIC OXIDE CALCIUM CARBONATE CARNAUBA WAX D&C RED NO. 27 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOLS Polyvinyl Acetate Phthalate POVIDONES PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 44;326" ], "ask_doctor": [ "Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persist over a period of 2 weeks" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions do not chew or crush tablets do not take within 1 hour after taking an antacid or milk adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement" ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) protect from moisture see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use in children under 6 years of age in persons who cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel RITE AID® PHARMACY *Compare to the active ingredient in Correctol® laxative for women bisacodyl USP, 5 mg stimulant laxative gentle, dependable overnight relief enteric coated 90 TABLETS 5 mg EACH TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Correctol®. 50844 REV0412B32652 DISTRIBUTED BY: Rite Aid Corporation 30 Hunter Lane, Camp Hill, PA 17011 Rite Aid 44-326 Rite Aid 44-326" ], "indications_and_usage": [ "Uses for gentle, overnight relief of occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "f90df709-cc94-4d3d-bb6d-6fed26fb3b2b", "id": "7a3c8a71-17e9-4078-b49c-78d711f08fc2", "active_ingredient": [ "Active ingredient (in each enteric coated tablet) Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose
children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20110216", "inactive_ingredient": [ "Inactive ingredients Scutellaria baicalensis root, platycodon grandiflorum leaf, arctium lappa fruit, mint, FDC blue no. 2, FDC yellow no.5, FDC yellow no.6, titanium dioxide, soybean, forsythia suspensa fruit, lonicera japonica flower, hypromellose 2910 (15000 mpa.s), glycyrrhiza uralensis, notopterygium incisum root, phragmites australis root, polydextrose, polyethylene glycol 4000, schizonepeta tenufolia spike" ], "purpose": [ "Purpose Pain reliever-fever reducer Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 24 tablets in 24 hours, which is the maximum daily amount for this product child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Do not give to children under 6 years of age unless directed by a doctor." ], "when_using": [ "When using this product do not exceed recommended dosage avoid alcoholic beverages may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect) use caution when driving or operating machinery may cause excitability especially in children" ], "questions": [ "Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm you may also use this number to report serious adverse events associated with the use of this product" ], "spl_product_data_elements": [ "YINCHIAO ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE SCUTELLARIA BAICALENSIS ROOT PLATYCODON GRANDIFLORUM LEAF ARCTIUM LAPPA FRUIT MINT FD&C BLUE NO. 2 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 TITANIUM DIOXIDE SOYBEAN FORSYTHIA SUSPENSA FRUIT LONICERA JAPONICA FLOWER HYPROMELLOSE 2910 (15000 MPA.S) GLYCYRRHIZA URALENSIS NOTOPTERYGIUM INCISUM ROOT PHRAGMITES AUSTRALIS ROOT POLYDEXTROSE POLYETHYLENE GLYCOL 4000 SCHIZONEPETA TENUFOLIA SPIKE YC YC YC" ], "ask_doctor": [ "Ask a doctor before use if the user has liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and older: 4 tablets every 4 to 6 hours, not to exceed 6 doses (24 tablets) in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 2 tablets every 4 to 6 hours, not to exceed 5 doses (10 tablets) in 24 hours, or as directed by a doctor children under 6 years: consult a doctor of age" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if sore throat is severe sore throat persists for more than 2 days sore throat is accompanied or followed by: fever headache rash nausea vomiting any of the following occurs (these could be signs of a serious condition): pain or fever persists or gets worse or new symptoms occur redness or swelling is present" ], "storage_and_handling": [ "Other information keep tightly sealed store between 15º to 30º C (59º to 86º F)" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for pain for more than 10 days (for adults) or 5 days (for children) for fever for more than 3 days" ], "package_label_principal_display_panel": [ "YINCHIAO, NDC58975-022-01, Acetaminophen - Pain Reliever-Fever Reducer, Chlorpheniramine Maleate - Antihistamine, See new warnings information, 120 Tablets IMAGE OF CARTON" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold, the flu, or hay fever: minor aches and pains headache sore throat sneezing runny nose itchy, watery eyes itching of the nose or throat temporarily reduces fever" ], "set_id": "f94ed467-b986-4ee2-b0df-f5f6d7e87a15", "id": "01043c5c-934e-4074-9540-156ef4324e24", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 162.5 mg Chlorpheniramine maleate 1 mg" ] }, { "effective_time": "20110415", "purpose": [ "Purpose Antiseptic", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Purpose Triple Antibiotic", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Purpose Purpose: First aid antiseptic, external analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of Children. If ingested, contact a Poison Control Center right away." ], "when_using": [ "When using this product: take with food or milk if stomach upset occurs" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301 GFA Production Xiamen Co., Ltd No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100 Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Flammable - keep away from fire or flame.", "Other information: Store at room temperature.", "Store at 59-86 degree F (15-30 degree C)", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Other Information: Store at room temperature (do not freeze). Taper evident sealed packets. Do not use packet if opened or torn." ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns" ], "set_id": "f993a178-78a6-410d-b480-b7dbe3639b05", "id": "2f632b22-3649-433d-b2fa-748e01085413", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient (in each tablet) Purpose Acetaminophen 325 mg ............. Analgesic/antipyretic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredients ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine" ], "warnings": [ "Warnings Warning: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings For external use only.", "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings For external use only" ], "spl_product_data_elements": [ "Easy Care First Aid - All Purpose BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE WHITE AZ;234 Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN White 44;352 Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE ALOE VERA LEAF CETYL ALCOHOL DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL POLYETHYLENE GLYCOL PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID" ], "ask_doctor": [ "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and children 2 years of age and older clean affected area. apply a small amount of this product on the area 1 to 3 times daily. may be covered with a sterile bandage children under 2 years of age: consult a doctor" ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days condition clears up and occurs again within a few days" ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week Do not use: in the eyes or apply over large areas of the body. longer than 1 week unless directed by a doctor. in large quantities, particularly over raw surfaces or blistered areas. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns. When using this product, avoid contact with the eyes." ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "Burn Cream", "Genuine Triple Antibiotic", "Non Aspirin", "Anitseptic Towelette", "Insect Sting Relief Pad", "Ibuprofen 200mg", "On The Go First Aid" ] }, { "effective_time": "20120514", "purpose": [ "Purpose Pain Reliever/ Fever Reducer" ], "keep_out_of_reach_of_children": [ "keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away." ], "when_using": [ "when using this product take food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions? (866) 562-2756 Adverse drug event call:" ], "pregnancy_or_breast_feeding": [ "if pregnant or breast feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "storage_and_handling": [ "other information store between 20 - 25 C (68 - 77 F) o o o o avoid high humidity and excessive heat above 40 C (104 F) o o : do not use if imprinted seal under the cap is broken or missing Tamper Evident" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pain due to temporarily reduces fever minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches" ], "set_id": "f9daa95b-51d6-48d5-ba2c-385066f382a8", "id": "9ea7ee06-a331-4c5c-873d-b2193d79e645", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active Ingredient (in each tablet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ], "dosage_and_administration_table": [ "
Adults and children 12 years and older take one tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow# 10, FD & C blue# 2, FD & C red# 40, FD & C yellow# 6, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, red iron oxide, titanium dioxide" ], "warnings": [ "Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you hives facial swelling asthma (wheezing) shock skin reddening rash blisters are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks everyday while using this product take more or for a longer time than directed" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POLYSORBATE 80 FERRIC OXIDE RED TITANIUM DIOXIDE IBU200" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take one tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor" ], "stop_use": [ "stop use and ask a doctor if you experience any of the following signs of stomach bleeding pain gets worse or last for more than 10 days fever gets worse or last more than 3 days redness or swelling is present in the painful area any new symptoms appear feel faint vomit blood have bloody or black stools have stomach pain that does not get better" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "IBUPROFEN TABLET, FILM COATED Label Image" ] }, { "effective_time": "20110504", "purpose": [ "Purpose Antiseptic", "Purpose Triple Antibiotic", "Purpose antiseptic, germicidal", "Purpose Antimicrobial", "Purpose Purpose: First aid antiseptic, external analgesic", "Purpose Pain reliever/fever reducer", "Purpose Analgesic/antipyretic", "Purpose Pain Reliever / fever reducer", "Uses: For flushing or irrigating the eyes to remove loose foreign material, air pollutants, or chlorinated water.", "Purpose Antiseptic", "Purpose Topical Anesthetic Antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children For external use only.", "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of Children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs" ], "description": [ "LOT/EXP: Made in CHINA 20130301 GFA Production Xiamen Co., Ltd No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100 Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "Code No.: GUJ/DRUG/G/1080 Batch No.: Mfg Date: Exp: Date:", "Made in CHINA LOT/EXP:" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "general_precautions": [ "tamper evident sealed packets; do not use any open or torn packets" ], "storage_and_handling": [ "Other information: Store at room temperature.", "Other Information: Store at room temperature (do not freeze). Taper evident sealed packets. Do not use packet if opened or torn.", "Other information Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59-86 degree F (15-30 degree C)", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store in a cool place. For irrigation only. Discard unused portion of the solution. Not for injection.", "Flammable - keep away from fire or flame Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)", "Flammable - keep away from fire or flame." ], "indications_and_usage": [ "Use For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.", "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Uses Provides, antiseptic germicidal skin preperation for minor invasive procedures", "Uses For handwashing to decrease bacteria on the skin.", "Uses First aid to help prevent infection and for the temporary relief of pain and itching associated with: Minor Cuts Scrapes Burns", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses temporary relief of minor aches and pains associated with: common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Use For preparation of skin before injection.", "Uses Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites." ], "set_id": "fa23be25-61c3-491c-b9e6-a5275c9bdc13", "id": "f1c6e667-8c30-4519-a961-98546c966463", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug" ], "active_ingredient": [ "Active Ingredient Active Ingredient: Benzalkonium Chloride 0.40%", "Active Ingredients Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient One Prep pad saturated with a 10% Povidone-Iodine solution equivalent to 1% available iodine", "Active Ingredient Ethyl Alcohol 62%", "Active Ingredients ACTIVE INGREDIENTS: Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%", "Active Ingredient (in each tablet) Ibuprofen USP (NSAID*) 200mg *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Acetaminophen 325 mg", "Active Ingredient (in each tablet) Aspirin (NSAID * ) 325 mg *nonsteroidal anti-inflammatory drug", "Active Ingredient: Purified Water USP...q.s.", "Active Ingredient Active Ingredient: Isopropyl Alcohol, 70% v/v", "Active Ingredient Active Ingredient: Purpose: Benzocaine, 6% w/v SD alcohol, 60% w/v" ], "inactive_ingredient": [ "Inactive Ingredients Inactive Ingredient: Purified water", "Inactive Ingredient water", "Inactive Ingredients Purified water.", "Inactive Ingredients Propylene glycol, carbomer, titanium dioxide, purified water", "Inactive Ingredients Aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, irolamine", "Inactive Ingredients cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients Cornstarch, polyethylene glycol, stearic acid, povidone", "Inactive Ingredients hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients: Sodium Chloride USP 44mg Monobasic Sodium Phosphate USP 18mg Sodium Phosphate Dibasic USP 111mg Edetate Disodium USP 10mg Benzalkonium Chloride 0.5mg NF (as preservative)", "Inactive Ingredient Purified water.", "Inactive Ingredients Purified water" ], "warnings": [ "Warnings Warning: For external use only.", "Warnings For external use only.", "Caution In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.", "Warnings For external use only. Flammable Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours", "Warnings For external use only", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warning: If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if solution changes color or becomes cloudy.", "Warnings For external use only.", "Warnings Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water." ], "spl_product_data_elements": [ "GFA First Aid 75 Person Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, POVIDONE-IODINE, WATER, ALCOHOL, ASPIRIN, IBUPROFEN, ACETAMINOPHEN, BENZOCAINE, ALCOHOL Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE LIDOCAINE ALOE VERA LEAF CETYL ALCOHOL DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL POLYETHYLENE GLYCOL PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER Povidone-Iodine Prep POVIDONE-IODINE POVIDONE-IODINE IODINE WATER Sterile Isotonic Buffered Genuine Eyewash WATER WATER WATER SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC EDETATE DISODIUM BENZALKONIUM CHLORIDE Genuine Hand Sanitizer ALCOHOL ALCOHOL ALCOHOL PROPYLENE GLYCOL TITANIUM DIOXIDE WATER Alcohol Cleansing Pad ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER Insect Sting Relief Pad BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER Ibuprofen IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;352 White NON-ASPIRIN ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL STEARIC ACID POVIDONE White AZ;234 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN White 44;157;ASPIRIN" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if the user has liver disease", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.", "Directions Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "Directions Clean intended area thoroughly with pad. Discard after single use.", "Directions Empty contents into palm. Rub hands until gel dissipates. Recommended for repeated use.", "Directions Adults and children 2 years of age and older clean affected area. apply a small amount of this product on the area 1 to 3 times daily. may be covered with a sterile bandage children under 2 years of age: consult a doctor", "Directions do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Adults and Children Take 2 tablets every 4 to 6 hours as 12 years of age needed. Do not take more than 12 tablets or older in 24 hours. Children 6-11 years Take 1 tablet every 4 to 6 hours as of age needed. Do not take more than 5 tablets in 24 hours. Children under 6 Do not use this regular strength product. years of age This will provide more than the recommended dose (overdose) and could cause serious health problems.", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Directions Remove contacts before using. Twist top to remove. Flush the affected area as needed. Control Rate of flow by pressure on the bottle. Do not touch tip of the container to any surface. Do not reuse. If necessary continue flushing with emergency eyewash or shower. Discard bottle after use.", "Directions Wipe Injection site vigorously and discard.", "Directions Clean intended area thoroughly with pad. Discard after single use." ], "stop_use": [ "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.", "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and consult a doctor if irritation and redness develop and persist for more than 72 hours", "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days condition clears up and occurs again within a few days", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs", "Stop use and ask a doctor if Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor." ], "spl_unclassified_section": [ "LOT/EXP: Made in CHINA 20130301", "LOT/EXP: Made in CHINA 20140301" ], "do_not_use": [ "Do not use in the eyes or over large areas of the body.", "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.", "Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week Do not use: in the eyes or apply over large areas of the body. longer than 1 week unless directed by a doctor. in large quantities, particularly over raw surfaces or blistered areas. Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns. When using this product, avoid contact with the eyes.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist; for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor", "Do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with electrocautery, in the eyes.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately." ], "package_label_principal_display_panel": [ "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID. Triple Antibiotic Ointment 10pcs Net wt. 0.9g (1/32oz) 100 Triple Antibiotic", "Antiseptic Povidone-Iodine Prep Pads medium Saturated with a 10% Povidone-Iodine Solution equavalent to 1% available iodine GFA Production Xiamen Co., Ltd. www.gfaproduction.com GFA Production Xiamen Co., Ltd. No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100 Wellkang Ltd t/a Wellkang Tech Consulting Suite B, 29 Harley Street LONDON W1G 9QR, England, United Kingdom", "Genuine Hand Sanitizer Instant Gel Antiseptic Handwash with Vitamin E and Aloe Kills 99.9% of germs without water Active Ingredient: Ethyl alcohol 62% Net Wt 0.9g (1/32oz)", "Genuine First Aid Burn Cream Antiseptic Pain Relief With Aloe Net Wt 0.9g (1/32 oz) Manufactured in CHINA for Genuine First Aid.", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "GENUINE FIRST AID 2 Tablets NON-ASPIRIN", "ASPIRIN 2 Tablets", "10ml Sterile Isotonic Buffered Genuine Eyewash For single use only", "Alcohol Cleansing Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID 100 Alcohol cleansing pads Reorder GFAP-39-02", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "Insect Sting Relief Pad", "Alcohol Cleansing Pad", "eyewash10ml", "Aspirin 325 mg", "Non Aspirin", "Ibuprofen 200mg", "Genuine Hand Sanitizer Individual", "Povidone-Iodine Prep Pads", "Genuine Triple Antibiotic", "Burn Cream", "Antiseptic Towelette", "GFA First Aid Kit", "GFA First Aid Kit" ] }, { "effective_time": "20091210", "inactive_ingredient": [ "Other Ingredients Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sucrose, Polyethylene Glycol, Starch, Dicalcium Phosphate, Ascorbyl Palmitate, dl-alpha Tocopherol, Sodium Ascorbate, Titanium Dioxide, Carmine Powder, Gelatin, Hydrogenated Soybean Oil, Polysorbate, Riboflavin CFR73.45, Triacetin. May contain Povidone and Polydextrose. Contains NO artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk-based by-products. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately. WARNING: Keep this and all drugs out of reach of children." ], "contraindications": [ "CONTRAINDICATIONS Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver." ], "precautions": [ "PRECAUTIONS Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "warnings": [ "WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately. WARNINGS: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins." ], "spl_product_data_elements": [ "Renate Prenatal Multivitamin and Minerals BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION RE;316" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one tablet daily, or as directed by a physician." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur." ], "how_supplied": [ "HOW SUPPLIED Renate is available as a dark pink caplet imprinted “RE316”: bottles of 100 caplets NDC 68032-316-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place. WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only" ], "package_label_principal_display_panel": [ "PACKAGING Sample Packaging: label" ], "indications_and_usage": [ "INDICATIONS AND USAGE Renate is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception. Renate: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid." ], "set_id": "fb53de79-2adb-4ec1-8d59-1224843f82c9", "id": "28c6a6d9-d7b2-4330-8a77-25891a118d7f" }, { "effective_time": "20150505", "inactive_ingredient": [ "Other Ingredients May Contain: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Hydroxypropyl Cellulose (Modified Cellulose), Magnesium Stearate, Silicon Dioxide, Sodium Citrate Dihydrate, Ascorbic Acid, Citric Acid, L-Glutathione, Hydroxypropyl Methylcellulose (Modified Cellulose), Polydextrose, Titanium Dioxide, Talc, Maltodextrin, Triglycerides, FD&C Yellow #6, FD&C Blue #2, FD&C Red # 40, Cellulose, Food Glaze, micro wax and other ancillary ingredients as needed to ensure product stability. Caution: This product contains FD&C Yellow #6, FD&C Blue #2 and FD&C Red # 40. Since additives, preservatives, bioavailability enhances, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality." ], "contraindications": [ "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated." ], "references": [ "REFERENCES: Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2. Federal Register Notice of April 9, 1971 (36 FR 6843). The Federal Register Notice of August 2, 1973 (38 FR 20750). The Federal Register Notice of October 17, 1980 (45 FR 69044). The Federal Register Notice of August 2, 1973 (38 FR 20750). Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000. The Federal Register Notice of March 5, 1996 (61 FR 8760). Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000. Code of Federal Regulations Title 21 Section 172.345. Code of Federal Regulations Title 21 Section 101.9(j)(8). Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7." ], "precautions": [ "PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress." ], "warnings": [ "WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study. 13 Patients undergoing cancer treatment should consult their licensed medical practitioner for advice." ], "pregnancy": [ "PREGNANCY and NURSING MOTHERS: Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating." ], "spl_product_data_elements": [ "levomefolate calcium, cyanocobalamin and pyridoxine hydrochloride levomefolate calcium, cyanocobalamin and pyridoxine hydrochloride LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STEARIC ACID HYDROXYPROPYL CELLULOSE (TYPE H) MAGNESIUM STEARATE SILICON DIOXIDE TRISODIUM CITRATE DIHYDRATE ASCORBIC ACID CITRIC ACID MONOHYDRATE GLUTATHIONE HYPROMELLOSES POLYDEXTROSE TITANIUM DIOXIDE TALC MALTODEXTRIN C10-18 TRIGLYCERIDES FD&C YELLOW NO. 6 FD&C BLUE NO. 2 FD&C RED NO. 40 POWDERED CELLULOSE SHELLAC MICROCRYSTALLINE WAX V326" ], "description": [ "DESCRIPTION: Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) should be administered under the supervision of a licensed medical practitioner. Each orange, tablet contains the following dietary ingredients: Supplement Facts Serving Size: 1 Tablet Servings per Container: 90 Amount per Serving % Daily Value L-Methylfolate Calcium contains less than 1% d-methylfolate. 1.13 mg Daily Value not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner. Cyanocobalamin 2 mg Pyridoxine HCl 25 mg" ], "openfda": {}, "version": "2", "adverse_reactions": [ "ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine." ], "spl_unclassified_section": [ "R x Prescription Dietary Supplement", "FOLATE MECHANISM OF ACTION: FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.", "FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood 4,5,6 . Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that \"The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added] 9,10\" . The actual amount and source of folate require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that \"dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated ... When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added] 7 .\" However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (R x )-folate regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345) 11 . In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B 6 , and Vitamin B 12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote \"... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B 12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B 12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B 12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added] 8 .\" Summary: This product is a dietary management product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.", "ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.", "INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product .", "DRUG INTERACTIONS: Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced serum folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Folinic acid may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.", "PHARMACOLOGY: FOLATE - Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. 3 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the \"methyl trap\" hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate 10 . Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate 10 .", "KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.", "PATIENT INFORMATION: Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) is a prescription dietary supplement to be used only under licensed medical supervision.", "KEEP THIS OUT OF REACH OF CHILDREN. Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344. Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) R x Prescription Dietary Supplement 90 ct. Bottle (90 tablets)", "Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL 33619 www.virtusRX.com MADE IN USA Virtus PHARMACEUTICALS Rev. 4/2014" ], "storage_and_handling": [ "STORAGE: Store at controlled room temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container." ], "how_supplied": [ "HOW SUPPLIED: Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) tablets are orange tablets debossed \"V326\", and are supplied in bottles of 90 tablets. NDC † 76439- 326 -90 (90 ct. bottle / 90 tablets) † This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Virtus PHARMACEUTICALS 76439- 326 -90 † Cyanocobalamin/ Levomefolate Calcium/ Pyridoxine HCl (2 mg-1.13 mg-25 mg) Prescription Vitamin B 9 -Containing Dietary Supplement R x 90 Tablets Made in the USA PRINCIPAL DISPLAY PANEL - 90 tablets" ], "indications_and_usage": [ "INDICATIONS AND USAGE: Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) is indicated for the distinct nutritional requirements of patients in need of advanced folate supplementation-specifically suboptimal folate or maintenance-level needs, as determined by a licensed medical practitioner. Cyanocobalamin/Levomefolate Calcium/Pyridoxine HCl (2 mg-1.13 mg-25 mg) should be administered under the supervision of a licensed medical practitioner." ], "set_id": "fb842e29-0c11-4541-887e-7f354a19b7a0", "id": "ed23cc4f-0274-4f6a-a30a-ccde1d0e220b", "description_table": [ "
Supplement Facts
Serving Size: 1 Tablet Servings per Container: 90
Amount per Serving % Daily Value
L-Methylfolate Calcium contains less than 1% d-methylfolate. 1.13 mg Daily Value not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
Cyanocobalamin 2 mg
Pyridoxine HCl 25 mg
" ] } ] }