{ "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": 47 } }, "results": [ { "effective_time": "20120917", "purpose": [ "PURPOSE Anti-diarrheal" ], "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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? Call 1800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "indications_and_usage": [ "USE Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "0d94a916-812b-479d-8576-c037db72fa4d", "id": "a475a511-e0ef-4fd3-a87a-f9d1fee81086", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCI USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use If you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are Taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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 (1-800-222-1222)." ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 TRISTEARIN MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN ANHYDROUS LACTOSE 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 ° – 25 ° C (68 ° – 77 ° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "do_not_use": [ "Do not use If you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 55319-554-53 FAMILY wellness ™ COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM ® A-D * Anti-Diarrheal Loperamide HCL Tablets USP, 2 mg Controls the Symptoms of Diarrhea 12 CAPLETS † Each caplet ( † capsule-shaped tablet) contains Loperamide HCl USP, 2 mg DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., 5085259/R0411 This is the 12 count blister carton label for Family Dollar Loperamide HCl tablets USP, 2 mg." ] }, { "effective_time": "20121226", "inactive_ingredient": [ "Inactive ingredients *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain." ], "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 asthma(wheezing) shock 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 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 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 asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes 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 allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area 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": [ "Aspirin Enteric Safety Coated Aspirin ASPIRIN ASPIRIN DIACETYLATED MONOGLYCERIDES ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 HYPROMELLOSES HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE YELLOW METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL DIMETHICONE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE FD&C YELLOW NO. 6 E;HEART;81" ], "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 asthma" ], "other_safety_information": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing †This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age 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 of age: consult 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 vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredient in Aspirin Regimen Bayer® 81 mg † SEE NEW WARNINGS INFORMATION Enteric safety Coated/ Aspirin regimen** **Ask your doctor before taking this product on a regular basis Aspirin 81 mg adult low strength Pain reliever (NSAID)* Low Dose Distributed by: American sales company 4201 Walden avenue, Lancaster, NY 14086 www.care1.info", "Product Label Aspirin 81 mg CareOne" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief." ], "set_id": "1877bc57-e5e0-431f-9d60-df3204245a6c", "id": "49f1fd90-884c-486c-87d4-f390a5b04093", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti- inflammatory drug" ] }, { "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": "20120201", "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide." ], "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 stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet(s) it may cause stomach discomfort, faintness or cramps do not use within 1 hour after taking an antacid or milk 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 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 chew or crush tablet(s) it may cause stomach discomfort, faintness or cramps do not use within 1 hour after taking an antacid or milk" ], "spl_product_data_elements": [ "The Medicine Shoppe Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE POVIDONE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TCL;003" ], "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": "1", "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 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" ], "spl_unclassified_section": [ "Other information each tablet contains: sodium less than 0.5mg store at 20°-25°C (68°-77°F) protect from excessive humidity TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel The Medicine Shoppe Gentle Laxative Overnight Relief of Constipation and Irregularity *Compare to the active ingredient of Dulcolax® LAXATIVE Bisacodyl USP, 5 mg 25 Coated Tablets CIN 1796986 Distributed By: The Medicine Shoppe International, Inc. Earth City MO 63045 www.medicineshoppe.com A Cardinal Health Company Questions? 1-800-325-1397 Medicine Shoppe Gentle Laxative 25ct" ], "indications_and_usage": [ "Use(s) for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "22cdf899-52f4-417f-93e4-a42881bd11cf", "id": "22cdf899-52f4-417f-93e4-a42881bd11cf", "active_ingredient": [ "Active ingredient(s) Bisacodyl USP 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": "20100930", "inactive_ingredient": [ "Inactive Ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide" ], "purpose": [ "PURPOSE Pain reliever" ], "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: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "ASPIRIN LOW DOSE Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 IRON METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE" ], "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 drink a full glass of water with each dose do not exceed recommended dosage 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: 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 20° to 25°C (68° to 77°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 for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product" ], "set_id": "24262441-3582-42b8-853e-6393bef275d1", "id": "24262441-3582-42b8-853e-6393bef275d1", "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 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100730", "inactive_ingredient": [ "INACTIVE INGREDIENTS Acetylated monoglycerides, anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, hypromellose, hypromellose phthalate, iron oxide ochre, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium dioxide." ], "purpose": [ "PURPOSE Pain reliever" ], "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: Qualitest Pharmaceuticals, 130 Vintage Drive, Huntsville, AL 35811, U.S.A. Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "ASPIRIN LOW DOSE Aspirin ASPIRIN 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink a full glass of water with each dose do not exceed recommended dosage 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: 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 20° to 25°C (68° to 77°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 Bliste of 30 Tablets Blister of 30 Tablets" ], "indications_and_usage": [ "USES for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product" ], "set_id": "283f3428-3cd4-4f43-92ae-06c4b2ff3f37", "id": "283f3428-3cd4-4f43-92ae-06c4b2ff3f37", "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 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120609", "inactive_ingredient": [ "Inactive ingredients: acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 lake, edible ink, FD&C yellow #6 lake, gelatin, iron oxide black, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, titanium dioxide" ], "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 stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than 2 weeks 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 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 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 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? Adverse drug event call: (866) 562-2756" ], "spl_product_data_elements": [ "Bisacodyl Bisacodyl BISACODYL BISACODYL ACACIA ANHYDROUS LACTOSE YELLOW WAX CALCIUM SULFATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERROSOFERRIC OXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SHELLAC POLYVINYL ACETATE PHTHALATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE S1" ], "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": "1", "dosage_and_administration": [ "Directions Take with a glass of water adults and children 12 years of age 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 20 - 25 0 C (68-77 0 F) Protect from excessive humidity" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Image of Package Label" ], "indications_and_usage": [ "For temporary relief of occasional constipation and irregularity This product generally produces bowel movement in 6 to 12 hours" ], "set_id": "29156c82-bb48-4356-860c-ca0e9001882e", "id": "a86fbc38-1f71-4abc-aade-e98304763076", "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age 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": "20131202", "inactive_ingredient": [ "Inactive ingredients aspartame, D&C red no. 7 calcium, dextrates, FD&C blue no. 1 lake, FD&C red no. 40 lake, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc" ], "purpose": [ "Purpose Acid reducer Antacid Antacid" ], "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 famotidine or other acid reducers Do not use • 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 you doctor. • with other acid reducers Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. 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": [ "Questions or comments? call toll-free 1-800-897-7535 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "Tums Dual Action famotidine, calcium carbonate and magnesium hydroxide FAMOTIDINE FAMOTIDINE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION ASPARTAME D&C RED NO. 7 DEXTRATES FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 GLYCERYL MONOSTEARATE ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 POVIDONES TALC light and dark pink TUMS;3" ], "ask_doctor": [ "Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • heartburn with l ightheadedness, sweating, or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ∘ do not swallow tablet whole: chew completely ∘ to relieve symptoms, chew 1 tablet before swallowing ∘ do not use more than 2 chewable 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." ], "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 • each tablet contains: calcium 320mg; magnesium 65mg • Phenylketonurics: Contains Phenylalanine 2.2mg per tablet • read the directions and warnings before use • read the bottle label. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture" ], "do_not_use": [ "Do not use • 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 you doctor. • with other acid reducers" ], "package_label_principal_display_panel": [ "Principal Display Panel TUMS DUAL ACTION Famotidine 10mg/Calcium Carbonate 800mg Magnesium Hydroxide 165mg Tablets ACID REDUCER+ANTACID JUST ONE TABLET relieves heartburn due to acid indigestion 50 CHEWABLE TABLETS BERRY FLAVOR Tips For Managing Heartburn • Do not lie flat or bend over after eating • Do not wear tight-fitting clothing around the stomach • Do not eat before bedtime • Raise the head of your bed • Avoid heartburn causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables • Eat slowly and avoid big meals • If overweight, lose weight • Quit smoking DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2008 GlaxoSmithKline www.tums.com 62079XA Tums Dual Action 50 tablet carton" ], "indications_and_usage": [ "Use relieves heartburn associated with acid indigestion and sour stomach" ], "set_id": "3305ba7c-a319-4bc8-a80d-ae714c0c3cb8", "id": "dcb09646-5c8a-48c5-989a-305850df2cc3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each chewable tablet) Famotidine 10mg Calcium carbonate 800mg Magnesium hydroxide 165mg" ] }, { "effective_time": "20140708", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, 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 are taking a diuretic you have asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition 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 ringing in the ears or a 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? call 1-888-838-2872, weekdays, 8 AM-5 PM ET" ], "spl_product_data_elements": [ "Aspirin EC Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM OXIDE FERRIC OXIDE YELLOW METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE Bi-convex" ], "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 asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea" ], "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 not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult 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", "Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960 Dist. 1993 0711REV 89 387R TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING ** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer ® Low Dose." ], "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 ringing in the ears or a loss of hearing occurs" ], "storage_and_handling": [ "Other information store at 25°C (77°F) excursions permitted between 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, 1 of 2 Enteric Aspirin 81 mg 500 count Bottle Label, Panel 1 of 2", "PRINCIPAL DISPLAY PANEL, 2 of 2 Enteric Aspirin 81 mg 500 count Bottle Label Text Goldline ® TAMPER-EVIDENT NDC 0182-1061-05 Adult Low Strength Enteric Aspirin DELAYED RELEASE ASPIRIN SAFETY COATED FOR ASPIRIN REGIMEN USERS PAIN RELIEVER (NSAID) THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 500 ENTERIC COATED TABLETS 81 mg EACH Compare to active ingredient of BAYER ® Low Dose Aspirin** Enteric Aspirin 81 mg 500 count Bottle Label, Panel 2 of 2" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur" ], "set_id": "3400a0eb-0d9d-473a-aa07-b4898f4b13b6", "id": "5718f0a6-b3e8-4a2d-962b-8f721b9eb81a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID nonsteroidal anti-inflammatory drug )" ] }, { "effective_time": "20130605", "spl_unclassified_section_table": [ "
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations.
", "
Count 81mg
30 67544-524-30
90 67544-524-60
" ], "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." ], "questions": [ "Questions? call 1-888-838-2872, weekdays, 8 AM-5 PM ET" ], "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." ], "storage_and_handling": [ "Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur" ], "set_id": "343539cf-038d-4b07-aa64-bddd3731e7e2", "id": "4022ec92-1e3c-40a7-9a23-e28f40e79a12", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID nonsteroidal anti-inflammatory drug )" ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate" ], "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 are taking a diuretic you have asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition 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 ringing in the ears or a 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Aspirin EC Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM OXIDE FERRIC OXIDE YELLOW METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE Bi-convex" ], "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 asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea" ], "openfda": {}, "version": "1", "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: consult a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960 Dist. 1993 0711REV 89 387R TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING ** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer ® Low Dose.", "Repackaging Information Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 81mg 30 67544-524-30 90 67544-524-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20130605AW Aphena Pharma Solutions - TN" ], "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 ringing in the ears or a 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": [ "PRINCIPAL DISPLAY PANEL - 81mg NDC 67544-524 - Aspirin 81mg Bottle Label 81mg" ] }, { "effective_time": "20110701", "inactive_ingredient": [ "Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate." ], "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." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: UDL Laboratories, Inc. Rockford, IL 61103 S-10314 R1 7/11" ], "spl_product_data_elements": [ "Loratadine loratadine LORATADINE LORATADINE ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES SODIUM LAURYL SULFATE white to off-white M;L;17" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "openfda": {}, "version": "7", "dosage_and_administration": [ "Directions (24 Hour Relief) adults and children 6 years and over 1 tablet daily; not 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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Original Prescription Strength Non-Drowsy Indoor and Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "Other information • TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 51079-538-20 LORATADINE TABLETS, USP 10 mg Antihistamine 100 Tablets (10 x 10) Original Prescription Strength Non-Drowsy * * When taken as directed. See enclosed leaflet . Indoor and Outdoor Allergies 24 Hour Relief (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING Drug Facts Active Ingredient (in each tablet) Purpose Loratadine USP, 10 mg . . . . . . . . . . . Antihistamine Uses See enclosed leaflet Warnings See enclosed leaflet Directions See enclosed leaflet Other Information • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • store between 20° to 25°C (68° to 77°F) ̣̣ • protect from excessive moisture Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. S-10315 R1 Packaged and Distributed by: UDL LABORATORIES, INC. ROCKFORD, IL 61103 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Loratadine Tablets 10 mg Unit Carton" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "34d4c2dc-5cbd-42f2-9334-b95b02187974", "id": "b428507c-8701-4365-afcc-617191109e0f", "active_ingredient": [ "Active ingredient (in each tablet) Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not 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
" ] }, { "effective_time": "20151016", "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide" ], "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 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 When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness and cramps 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 If pregnancy or breast-feeding, ask a health professions 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 chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk it may cause stomach discomfort, faintness and cramps" ], "questions": [ "Questions or comments? Call 1-800-660-2153" ], "spl_product_data_elements": [ "CRH Medsense Bisacodyl Stimulant Laxative Bisacodyl ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TALC TITANIUM DIOXIDE POLYVINYL ACETATE PHTHALATE SUCROSE POVIDONES FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE POLYETHYLENE GLYCOLS BISACODYL BISACODYL" ], "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": "2", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 yers of age 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 pregnancy or breast-feeding, ask a health professions 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" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 20°–25°C (68°–77°F) protect from excess humidity do not use if foil imprinted with “Bisacodyl Stimulant Laxative Tablet” is broken or missing" ], "package_label_principal_display_panel": [ "CRH Medsense Bisacodyl USP 5mg Stimulant Laxative, 10 tablets (69041-002-01) NDC 69041-002-01 CRH Medsense Bisacodyl USP 5mg Stimulant Laxative Tablets Gentle, predictable overnight relief 10 Comfort Coated Tablets Front Back" ], "indications_and_usage": [ "Use for relief of occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours" ], "set_id": "374b484f-6447-4944-8755-f13b258ea5f1", "id": "22396f82-4566-4957-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl USP 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 yers of age 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": "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": "20120430", "purpose": [ "Purpose Antiemetic" ], "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 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? call 1-800-382-7219" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20-25°C (68-77°F) do not use if carton is opened or if blister unit is broken or torn see side panel for lot number and expiration date" ], "indications_and_usage": [ "Use for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness" ], "set_id": "443a3771-9195-4dd0-b07d-46b01f665036", "id": "83dee8a0-04ec-48ac-93a5-da8ccbaf125e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Dimenhydrinate 50 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 2 tablets every 4-6 hours do not take more than 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years give ½ to 1 tablet every 6-8 hours do not give more than 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years give ½ tablet every 6-8 hours do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose" ], "warnings": [ "Warnings Do not use for children under 2 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are 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 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Dramamine Original Formula Dimenhydrinate Dimenhydrinate Dimenhydrinate anhydrous lactose silicon dioxide croscarmellose sodium magnesium stearate cellulose, microcrystalline Standard biconvex DRAMAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over take 1 to 2 tablets every 4-6 hours do not take more than 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years give ½ to 1 tablet every 6-8 hours do not give more than 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years give ½ tablet every 6-8 hours do not give more than 1-1/2 tablets in 24 hours, or as directed by a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "do_not_use": [ "Do not use for children under 2 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-313-36 Dimenhydrinate Tablets/Antiemetic Dramamine ® ORIGINAL FORMULA Fast Acting Motion Sickness Relief For Children and Adults 36 TABLETS (50 mg EACH) Principal Display Panel" ] }, { "effective_time": "20130206", "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "purpose": [ "PURPOSE Anti-diarrheal" ], "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: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use If you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are Taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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 (1-800-222-1222)." ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? Call 1800-406-7984" ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 TRISTEARIN MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor", "OTHER INFORMATION store between 20 ° – 25 ° C (68 ° – 77 ° F) see side panel for batch number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "do_not_use": [ "Do not use If you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL SHOPKO ® * Compare to the active ingredient of Imodium ® A-D Anti-Diarrheal Loperamide HCl Tablets USP, 2 mg Anti-Diarrheal Controls The Symptoms of Diarrhea 24 Caplets * Each caplet ( * capsule-shaped tablet) contains Loperamide HCl USP, 2 mg Manufactured by: Ohm Laboratories Inc. 5093693/R0212 This is the 24 count blister carton label for Shopko Loperamide HCl tablets USP, 2 mg." ], "indications_and_usage": [ "USE Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "47604b25-b0b9-408e-a62b-fa785cca8958", "id": "afec31fa-c850-499e-9f87-475eec5ce0d4", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCI USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ] }, { "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": "20130909", "inactive_ingredient": [ "anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid." ], "purpose": [ "Purpose: Antihistamine>" ], "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 Ask a doctor before use if you have: glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland" ], "when_using": [ "When using this product: excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery" ], "spl_product_data_elements": [ "Allergy Time Chlorpheniramine Maleate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ANHYDROUS LACTOSE SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STEARIC ACID TCL242" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours Children under 6 years of age - do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "package_label_principal_display_panel": [ "This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States 100 CT LABEL" ], "indications_and_usage": [ "Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itch, watery eyes" ], "set_id": "4a1aa746-7568-426e-838f-d3bd663e9204", "id": "d47df14d-46f6-4b35-ae73-4a9b59825c31", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg" ] }, { "effective_time": "20130729", "inactive_ingredient": [ "INACTIVE INGREDIENT Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide." ], "purpose": [ "OTC - PURPOSE Stimulant laxative." ], "keep_out_of_reach_of_children": [ "OTC - 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": [ "OTC - WHEN USING 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." ], "spl_product_data_elements": [ "Bisacodyl Bisacodyl BISACODYL BISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE POLYVINYL ACETATE PHTHALATE TCL;003" ], "ask_doctor": [ "OTC - ASK DOCTOR If you have Stomach pain, nausea or vomiting A sudden change in bowel habits that lasts for more than 2 weeks." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION 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 1 tablet in a single daily dose Children under 6 years Ask a doctor OTHER INFORMATION Store at 20(-25(C(68(-77(F). Protect from excessive humidity." ], "pregnancy_or_breast_feeding": [ "OTC - PREGNANCY OR BREAST FEEDING Ask a health professional before use." ], "stop_use": [ "OTC - STOP USE And ask a doctor if: You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition. You need to use laxative for more than 1 week" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 8f6065f1-figure-01" ], "indications_and_usage": [ "INDICATIONS AND USAGE For temporary relief of occasional constipation and irregularity This product generally produces bowel movement in 6 to 12 hours." ], "set_id": "4affb1e6-4804-448e-b10f-15f2aac0aedc", "id": "8f6065f1-bb7c-4422-8f81-e6da2e56b22d", "active_ingredient": [ "OTC - ACTIVE INGREDIENT Bisacodyl USP 5mg." ], "dosage_and_administration_table": [ "
Adults and children 12 years and over 1 to 3 tablets in a single daily dose
Children 6 to under 12 years 1 tablet in a single daily dose
Children under 6 years Ask a doctor
" ] }, { "effective_time": "20110728", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, corn starch, D&C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose" ], "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." ], "warnings": [ "Warnings Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland" ], "when_using": [ "When using this product • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number." ], "spl_product_data_elements": [ "Chlorpheniramine Maleate chlorpheniramine maleate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE ANHYDROUS LACTOSE STARCH, CORN D&C YELLOW NO. 10 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE 44;194" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions (4 Hour) adults and children 12 years of age and over 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours. children 6 to under 12 years of age 1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceed 3 whole tablets in 24 hours. children under 6 years of age 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." ], "spl_unclassified_section": [ "ALLERGY RELIEF TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "Other information • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] • protect from excessive moisture • use by expiration date on blister package", "How Supplied: Chlorpheniramine Maleate Tablets are available as follows: 4 mg - Yellow, round, convex tablets are bisected with 44 over 194 imprinted on one side of the tablet. NDC 51079-163-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: LNK International, Inc. Hauppauge, NY 11788 Distributed by: UDL Laboratories, Inc. Rockford, IL 61103 S-5563 R10 7/11" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 4 mg NDC 51079-163-20 CHLORPHENIRAMINE MALEATE TABLETS 4 mg Antihistamine 100 Tablets (10 x 10) Protect from excessive moisture. ALLERGY RELIEF 4 Hour (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Manufactured by: LNK International, Inc. Hauppauge, NY 11788 S-5562 R13 Packaged and Distributed by: UDL LABORATORIES, INC. ROCKFORD, IL 61103 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Chlorpheniramine Maleate Tablets 4 mg Carton Unit Carton" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "4eab8135-cb0a-40b0-bf5d-a0d42e6e1968", "id": "009b03d6-8b2f-404c-be24-4a240f9dc98b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg" ], "dosage_and_administration_table": [ "
(4 Hour)
adults and children 12 years of age and over 1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.
children 6 to under 12 years of age 1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceed 3 whole tablets in 24 hours.
children under 6 years of age do not use this product in children under 6 years of age
" ] }, { "effective_time": "20120802", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, 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. Keep out of reach of children." ], "warnings": [ "Warnings Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome: 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. Aspirin may cause a severe allergic reaction, which may include: Allergy alert: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing) This product contains an NSAID, which may cause severe stomach Stomach bleeding warning: 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 ■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use ■ stomach bleeding warning applies to you Ask a doctor before use if ■ 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 not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for diabetes, gout, or arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if ■ 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 ■ ringing in the ears or a loss of hearing occurs , ask a health professional before use. It is especially important not If pregnant or breast-feeding 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." ], "questions": [ "Questions? Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Aspir Low Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE YELLOW METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE" ], "openfda": {}, "version": "2", "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: consult a doctor" ], "spl_unclassified_section": [ "Other Information ■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) ■ use by expiration date on package **Compare to the active ingredient in Low Dose BAYER® **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose. Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150 USA ASPIR LOW™ LOW STRENGTH 81mg ASPIRIN (NSAID) Enteric Coated 1 1/4 gr. (81 mg) each Analgesic SEE NEW WARNINGS INFORMATION NEW Tablet Appearance THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN MAJOR®" ], "package_label_principal_display_panel": [ "ASPIR LOW (ASPIRIN) TABLET Label Image" ], "indications_and_usage": [ "Uses ■ temporarily relieves minor aches and pains ■ for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur" ], "set_id": "50c157d7-ea12-4a55-82ba-4190bd1fd4c5", "id": "3afa1966-3613-4e1b-b9ab-5b2712df183e", "active_ingredient": [ "Active ingredient Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20131203", "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose" ], "contraindications": [ "CONTRAINDICATIONS Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic mega-colon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. Donnatal® is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement." ], "precautions": [ "PRECAUTIONS Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur." ], "warnings": [ "WARNINGS In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Donnatal® may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction." ], "pregnancy": [ "PREGNANCY PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with Donnatal®. It is not known whether Donnatal® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® is administered to a nursing woman." ], "spl_product_data_elements": [ "Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE PHENOBARBITAL PHENOBARBITAL HYOSCYAMINE SULFATE HYOSCYAMINE ATROPINE SULFATE ATROPINE SCOPOLAMINE HYDROBROMIDE SCOPOLAMINE ANHYDROUS LACTOSE CALCIUM STEARATE SILICON DIOXIDE STARCH, CORN CELLULOSE, MICROCRYSTALLINE D;Donnatal" ], "description": [ "Description Each Donnatal® Tablet contains: Phenobarbital, USP....................................... 16.2 mg Hyoscyamine Sulfate, USP...................... 0.1037 mg Atropine Sulfate, USP ...............................0.0194 mg Scopolamine Hydrobromide, USP ...........0.0065 mg INACTIVE INGREDIENTS: Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a minimum of adverse effects. Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity of symptoms." ], "adverse_reactions": [ "ADVERSE REACTIONS Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angiodema and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions." ], "how_supplied": [ "How Supplied Donnatal® Tablets are supplied as: White, D-shaped tablets debossed “D” on one side and “Donnatal” on the other side. Bottles of 100 tablets. Bottles of 1000 tablets. AVOID FREEZING Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser. Also available: Donnatal Extentabs® Tablets, the only extended release formulation, in bottles of 100 and 500 tablets. Donnatal® Elixir, a purple colored, grape flavored liquid, in 4 fl oz (118 mL) and 1 pint (473 mL) bottles." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Donnatal label_100 tablets Donnatal label_1000 tablets Donnatal label_100 tablets Donnatal label_1000 tablets" ], "indications_and_usage": [ "INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation." ], "set_id": "54f28743-bb66-4234-8d20-8502a5ffdc26", "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential." ], "id": "05653083-535e-473b-bd53-e17df9ddc1dd", "overdosage": [ "OVERDOSAGE The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be used." ] }, { "effective_time": "20120430", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, corn starch, colloidal silicon dioxide, D&C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose" ], "purpose": [ "Purpose Antiemetic" ], "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 Do not use for children under 12 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlarged prostate gland Ask a 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 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. (1-800-222-1222)" ], "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 or comments? call 1-800-382-7219" ], "spl_product_data_elements": [ "Dramamine Less Drowsy Formula Meclizine Hydrochloride Meclizine Hydrochloride Meclizine anhydrous lactose starch, corn silicon dioxide D&C yellow NO. 10 aluminum oxide magnesium stearate cellulose, microcrystalline Flat faced bevelled edge DRAMAMINE" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions take first dose one hour before starting activity adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "storage_and_handling": [ "Other information store between 20 – 25°C (68 – 77°F) do not use if blister is broken or torn" ], "do_not_use": [ "Do not use for children under 12 years of age unless directed by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-312-08 Meclizine hydrochloride tablets/Antiemetic Dramamine ® LESS DROWSY FORMULA Provides Up To 24 Hours of Motion Sickness Protection Protection With Less Drowsiness! 8 TABLETS (25 mg EACH) PRINCIPAL DISPLAY PANEL" ], "indications_and_usage": [ "Use for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness" ], "set_id": "636e4941-b51c-4ed1-92c2-ced3b5c92005", "id": "57d9067b-1f0b-4e3f-9647-583b24f50e3f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient (in each tablet) Meclizine HCl 25 mg" ] }, { "effective_time": "20150511", "inactive_ingredient": [ "Inactive ingredients Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate" ], "purpose": [ "PURPOSE Pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately." ], "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 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 other pain relievers/fever reducers Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have 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 a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: feel faint, vomits blood, have bloody or black stools, have stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ you may report side effects to 1-888-952-0050 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 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 accidental overdose, contact a doctor or Poison Control Center immediately. Directions ■ drink a full glass of water with each does ■ 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: consult a doctor Other information ■ save carton for full directions and warnings ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN CARNAUBA WAX SODIUM LAURYL SULFATE COLLOIDAL SILICON DIOXIDE SODIUM HYDROXIDE D&C YELLOW NO. 10 ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE DIMETHICONE A" ], "ask_doctor": [ "Ask a doctor before use if ■ stomach bleeding warning applies to you ■ you have 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": "2", "dosage_and_administration": [ "Directions ■ drink a full glass of water with each does ■ 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: consult 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 specifically 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, vomits blood, have bloody or black stools, have stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ you may report side effects to 1-888-952-0050" ], "do_not_use": [ "Do not use ■ if you are allergic to aspirin or other pain relievers/fever reducers" ], "package_label_principal_display_panel": [ "DISPLAY PANEL Aspirin81EC50ct.jpg" ], "indications_and_usage": [ "USES ■ relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief" ], "set_id": "6618f1ec-7d20-4284-ae3a-feea7573d0ae", "id": "a4e563ce-7e7d-40ae-b8bd-75fd1f2a4acf", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH TABLET) Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20100930", "inactive_ingredient": [ "Inactive ingredients Anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "purpose": [ "Purpose Antidiarrheal" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of the reach of children . In case of accidental overdose, contact a physician or Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl Do not use if you have bloody or black stool Ask a doctor before use if you have a fever mucus in stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics When using this product tiredness, drowsiness or dizziness may occur be careful when driving or operating machinery Stop use and ask a doctor if symptoms get worse diarrhea lasts more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If you are pregnant or breast feeding , ask a health professional before use. Keep this and all drugs out of the reach of children . In case of accidental overdose, contact a physician or Poison Control Center right away." ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur be careful when driving or operating machinery" ], "questions": [ "Questions or comments? 1-800-835-2263" ], "spl_product_data_elements": [ "Physicians Care Anti-Diarrheal Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN green OVAL 123" ], "ask_doctor": [ "Ask a doctor before use if you have a fever mucus in stool a history of liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours. Children under 12 years: Do not give to children under 12 years of age." ], "pregnancy_or_breast_feeding": [ "If you are pregnant or breast feeding , ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "Other information store at room temperature 59º - 86ºF (15º - 30ºC) tamper-evident sealed packets do not use any opened or torn packet" ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse diarrhea lasts more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition." ], "do_not_use": [ "Do not use if you have bloody or black stool" ], "package_label_principal_display_panel": [ "Principal Display Panel - 200R Physicians Care Antidiarrheal Label Physicians Care ® Anti-Diarrheal Controls Symptoms of Diarrhea Loperamide Hydrochloride 2 mg Pull To Open Easy to Swallow COATED CAPLETS Compare Active ingredient to: Imodium AD Registered Trademark of McNeil Consumer & Specialty Pharmaceuticals Tamper-Evident Unit Dose Packets Physicians Care ® Registered Trademark of ACME UNITED Corporation 50 PACKETS (1 Caplet 2 Mg Each) Principal Display Panel - 200R Physicians Care Antidiarrheal Label" ], "indications_and_usage": [ "Uses Controls the symptoms of diarrhea, including Travelers diarrhea." ], "set_id": "67272c12-784b-468f-969e-01a1f3a265a8", "id": "ff65d0fd-f71d-494d-bd18-f6c1f4d5b7b0", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking antibiotics" ], "active_ingredient": [ "Active ingredient (in each caplet) Loperamide Hydrochloride 2mg" ] }, { "effective_time": "20120927", "purpose": [ "PURPOSE Anti-diarrheal" ], "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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? Call 1800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "indications_and_usage": [ "USES Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "6d086c18-eb09-46ec-9628-2d8676c17c7c", "id": "e887e062-0b65-4612-b0bf-ea04f01cdbdb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCI USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use If you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are Taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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." ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 TRISTEARIN MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 ° – 25 ° C (68 ° – 77 ° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "do_not_use": [ "Do not use If you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL select brand ® NDC 15127-338-12 Loperamide Hydrochloride Tablets USP, 2 mg ANTI-DIARRHEAL Controls The Symptoms Of Diarrhea ٭ Compare to the active ingredient of Imodium ® A-D 12 Caplets * Each Caplet ( * capsule-shaped tablet) contains Loperamide HCl USP, 2 mg 5048836/R1109 This is the 12 count blister carton label for Select Brand Loperamide HCl tablets USP, 2 mg." ] }, { "effective_time": "20131203", "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose" ], "contraindications": [ "CONTRAINDICATIONS Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic mega-colon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. Donnatal® is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement." ], "precautions": [ "PRECAUTIONS Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur." ], "warnings": [ "WARNINGS In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Donnatal® may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction." ], "pregnancy": [ "PREGNANCY PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with Donnatal®. It is not known whether Donnatal® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® is administered to a nursing woman." ], "spl_product_data_elements": [ "Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE PHENOBARBITAL PHENOBARBITAL HYOSCYAMINE SULFATE HYOSCYAMINE ATROPINE SULFATE ATROPINE SCOPOLAMINE HYDROBROMIDE SCOPOLAMINE ANHYDROUS LACTOSE CALCIUM STEARATE SILICON DIOXIDE STARCH, CORN CELLULOSE, MICROCRYSTALLINE D;Donnatal" ], "description": [ "Description Each Donnatal® Tablet contains: Phenobarbital, USP....................................... 16.2 mg Hyoscyamine Sulfate, USP...................... 0.1037 mg Atropine Sulfate, USP ...............................0.0194 mg Scopolamine Hydrobromide, USP ...........0.0065 mg INACTIVE INGREDIENTS: Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a minimum of adverse effects. Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity of symptoms." ], "adverse_reactions": [ "ADVERSE REACTIONS Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angiodema and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions." ], "how_supplied": [ "How Supplied NDC:68151-0607-1 in a PACKAGE of 1 TABLETS" ], "package_label_principal_display_panel": [ "Belladonna Alkabids/Phenorbarb TAB Label Image" ], "indications_and_usage": [ "INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation." ], "set_id": "7343cfab-9bd9-4dcb-bbef-9592ffd5d7e6", "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential." ], "id": "edc24a6c-4754-4695-af73-de2797457ba7", "overdosage": [ "OVERDOSAGE The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be used." ] }, { "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": "20120426", "purpose": [ "PURPOSE Anti-diarrheal" ], "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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? call 1800-406-7984 Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "OTHER INFORMATION store between 20° – 25° C (68° – 77° F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "indications_and_usage": [ "USE(S) controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "812d636c-82d5-4eef-b154-cdf065943122", "id": "d30f22f1-8c60-4072-bcdb-ac5d41edb796", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCl USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use if you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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." ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN TRISTEARIN ANHYDROUS LACTOSE 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "do_not_use": [ "Do not use if you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54868-6312-0 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet ( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D This is the 12 count blister carton label for Loperamide hydrochloride tablets." ] }, { "effective_time": "20120605", "inactive_ingredient": [ "Inactive ingredients Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate." ], "purpose": [ "Purpose Antihistamine" ], "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 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 Do not use with ny other product containing diphenhydramine, including products used topically. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives taking other products containing diphenhydramine When using this product Do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery If pregnant or breastfeeding ask a health professional before use." ], "spl_product_data_elements": [ "diphenhydramine hydrochloride diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE STARCH, CORN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN ANHYDROUS LACTOSE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE pink top/pink body E649" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours. Children 12 years and under: Consult a Doctor" ], "storage_and_handling": [ "Storage and Handling Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 L1812 Rev. 11/08 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "how_supplied_table": [ "
Bottles of 30 NDC 54868-1050-1
Bottles of 100 NDC 54868-1050-5
" ], "how_supplied": [ "HOW SUPPLIED DiphenhydrAMINE Hydrochloride Capsules USP 50 mg Bottles of 30 NDC 54868-1050-1 Bottles of 100 NDC 54868-1050-5" ], "package_label_principal_display_panel": [ "Package Label - Principal Display Panel NDC 54868-1050-1 DiphenhydrAMINE Hydrochloride Capsules USP 50 mg 30 Capsules 50 mg x 30 Capsules - Label" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose and sneezing itching of the nose or throat itchy, watery eyes." ], "set_id": "8975a041-76dd-4c5e-aa83-e1021d55a084", "id": "3144133b-0993-4e96-b5c1-78a79dbad72b", "active_ingredient": [ "Active ingredient (in each capsule) Diphenhydramine Hydrochloride 25 mg Diphenhydramine Hydrochloride 50 mg" ] }, { "effective_time": "20121121", "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide" ], "purpose": [ "Purpose 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" ], "when_using": [ "When using this product do not take dose within one hour of taking an antacid or milk you may experience abdominal discomfort, faintness and cramps" ], "questions": [ "Questions or comments? call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday BOTTLE LABEL" ], "spl_product_data_elements": [ "Bisacodyl Stimulant Laxative Bisacodyl BISACODYL BISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE POVIDONE SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TCL;003" ], "ask_doctor": [ "Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions DO NOT CHEW TABLETS adults and children 12 years and over: 1-3 tablets once daily children 6 to 11 years: 1 tablet once daily children under 6 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 you have rectal bleeding you fail to have a bowel movement after use of this product These may indicate a serious condition." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use for longer than one week when abdominal pain, nausea or vomiting are present in children under 6 years of age in persons who cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Bisacodyl Delayed-Release Tablets USP, 5 mg Enteric Coated Stimulate Laxative NDC 54868-2497-0 100 tablets Distributed by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "indications_and_usage": [ "Uses relieves occasional constipation generally produces bowel movement in 6-12 hours" ], "set_id": "8b890125-9cd4-427b-8a6e-0070a58cca62", "id": "cc8e31d5-d163-400a-9ffe-7beeae5186fa", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl 5 mg" ] }, { "effective_time": "20140408", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "Purpose Pain reliever" ], "keep_out_of_reach_of_children": [ "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 Reyeʼs syndrome: Children and teenagers who have or are recovering from chicken pox or flulike 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 are taking a diuretic ■ you have asthma ■ you have not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for diabetes, gout, or arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug 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 ■ ringing in the ears or a 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." ], "questions": [ "Questions? Adverse Drug Event Call: (800) 616-2471" ], "spl_product_data_elements": [ "Aspir Low Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE YELLOW METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE" ], "openfda": {}, "version": "2", "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: consult a doctor" ], "spl_unclassified_section": [ "Other Information ■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) ■ use by expiration date on package **Compare to the active ingredient in BAYER® Low Dose **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose. 387R 0610 Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150 USA ASPIR LOW™ LOW STRENGTH 81mg ASPIRIN (NSAID) Enteric Coated 1 1/4 gr. (81 mg) each Analgesic SEE NEWWARNINGS INFORMATION NEWTablet Appearance THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN MAJOR® OI80410910 Cardinal Health Zanesville, OH 43701" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Aspir Low 1 1/4 gr. (81 mg) (NSAID) Enteric Coated Tablets Blister", "Carton Aspir Low 81 mg Aspirin (NSAID) Enteric Coated 1 1/4 gr. (81 mg) each Analgesic QTY 30 Carton" ], "indications_and_usage": [ "Uses ■ temporarily relieves minor aches and pains ■ for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur" ], "set_id": "95604767-87a3-4e33-a7bf-b207a361b62b", "id": "fb32bbfd-a619-4979-a35c-0e2ba96f00d6", "active_ingredient": [ "Active ingredient Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20151222", "purpose": [ "Purpose Anti-diarrheal" ], "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 tiredness, drowsiness or dizziness may occur be careful when driving or operating machinery" ], "questions": [ "Questions or comments? call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information do not use if carton or inner pouch is open or torn store between 68-77°F (20-25°C) see bottom panel of carton or pouch for expiration date and lot number" ], "indications_and_usage": [ "Use Controls symptoms of diarrhea, including Travelers' Diarrhea" ], "set_id": "97d018d0-a355-43f8-89f3-4ce21fa16fde", "id": "31630fe0-6fa9-4e3f-b8c4-d42e31c69389", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking antibiotics" ], "active_ingredient": [ "Active ingredient (in each caplet) Loperamide HCl 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children under 12 years do not use this product for children under 12 years of age
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow #10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "Warnings Allergy alert Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl. Do not use if you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics When using this product tiredness, drowsiness or dizziness may occur be careful when driving or operating machinery Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may 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. (1-800-222-1222)" ], "spl_product_data_elements": [ "Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride Loperamide Hydrochloride Loperamide Anhydrous Lactose Croscarmellose Sodium Crospovidone D&C yellow NO. 10 FD&C blue NO. 1 Magnesium Stearate Powdered Cellulose Starch, Corn 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea do not take more than directed adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children under 12 years do not use this product for children under 12 years of age" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition." ], "do_not_use": [ "Do not use if you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton Compare to the Active Ingredients in Imodium ® A-D* Lil' Drug Store ® Anti- Diarrheal Loperamide HCl, 2 mg Controls Symptoms of Diarrhea 4 CAPLETS Principal Display Panel - 4 Caplet Pouch Carton" ] }, { "effective_time": "20110118", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate" ], "purpose": [ "" ], "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" ], "spl_product_data_elements": [ "Adult Low Dose Aspirin Enteric Safety Coated Aspirin ASPIRIN ASPIRIN ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE YELLOW METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE embossed;upper;8;lower;plain" ], "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 asthma" ], "openfda": {}, "version": "1", "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; do not exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult 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: an allergic reaction occurs, Seek medical help right away. 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 ringing in the ears or a loss of hearing occurs These could be signs of a serious condition." ], "storage_and_handling": [ "store between 20° - 25°C (60° - 77°F) in a dry place" ], "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 BOTTLE LABEL" ], "indications_and_usage": [ "Uses for the temporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses of this product" ], "set_id": "a03d1d10-1aa3-40cf-97f3-16c86596e9c3", "id": "c0e15e03-c564-428a-b6c9-46d114062fd2", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: gout, or arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID*)................................Pain reliever *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110801", "drug_interactions": [ "Drug Interactions The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.", "DRUG INTERACTIONS Sentra PM does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of Sentra PM may allow for lowering the dose of co-administered drugs under physician supervision." ], "abuse": [ "Abuse and Dependence Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. As with any hypnotic, caution must be exercised in administering temazepam to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeated prescriptions without adequate medical supervision." ], "precautions": [ "PRECAUTIONS General Since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of temazepam is recommended as the initial dosage for such patients. Temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary. The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. If temazepam is to be combined with other drugs having known hypnotic properties or CNS-depressant; and effects, consideration should be given to potential additive effects. The possibility of a synergistic effect exists with the co-administration of temazepam and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam and diphenhydramine. A cause and effect relationship has not yet been determined (see CONTRAINDICATIONS ).", "PRECAUTIONS AND CONTRAINDICATIONS Sentra PM is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Sentra PM." ], "description": [ "DESCRIPTION Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro 1,3-dihydro-3-hydroxyl-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg, are for oral administration. 15 mg and 30 mg Capsules Active Ingredient: temazepam USP 15 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FDandC Blue #1, FDandC yellow # 5, FDandC yellow # 6, gelatin and titanium dioxide. May also include: benzyl alcohol, butylparaben, sodium lauryl sulfate, edetate calcium disodium, methylparaben, propyl paraben and sodium propionate. Imprinting ink may contain ammonium hydroxide, ethanol, 2-propanol, butanol, pharmaceutical shellac, potassium hydroxide, propylene glycol, black iron oxide, and other ingredents. 30 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: benzyl alcohol, butylparaben, sodium lauryl sulfate, edetate calcium disodium, methylparaben, propyl paraben and sodium propionate. Imprinting ink may contain ammonium hydroxide, ethanol, 2-propanol, butanol, pharmaceutical shellac, potassium hydroxide, propylene glycol, black iron oxide, and other ingredents. Structural Formula Benzodiazepine", "PRODUCT DESCRIPTION Primary Ingredients Sentra PM consists of a proprietary blend of amino acids, cocoa, ginkgo biloba and flavonoids in specific proportions. These ingredients fall into the category of “Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186. Amino Acids Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in Sentra PM are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Patients with sleep disorders may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to induce sleep. Patients with sleep disorders have altered serotonin metabolism. Some patients with sleep disorders have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance that is genetically determined. Patients with sleep disorders frequently cannot acquire sufficient tryptophan from the diet without ingesting a prohibitively large amount of calories, particularly protein rich calories. Flavonoids Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Sentra PM cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response. Other Ingredients Sentra PM contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material). Physical Description Sentra PM is a yellow to light brown powder. Sentra PM contains L-Glutamic Acid, 5-Hydroxytryptophan as Griffonia Seed Extract, Acetylcarnitine HCL, Choline Bitartrate, Cinnamon, Cocoa, Ginkgo Biloba, and Hawthorn Berry." ], "storage_and_handling": [ "Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].", "Storage Store at room temperature, 59-86OF (15-30OC). Protect from light and moisture." ], "pharmacokinetics": [ "CLINICAL PHARMACOLOGY Pharmacokinetics In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using 3H labeled drug, temazepam was well absorbed and found to have minimal (8%) first pass metabolism. There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate. The unchanged drug was 96% bound to plasma proteins. The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study population and method of determination. Metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. Thus, formation of the major metabolite is the rate limiting step in the biodisposition of temazepam. There is no accumulation of metabolites. A dose-proportional relationship has been established for the area under the plasma concentration/time curve over the 15 to 30 mg dose range. Temazepam was completely metabolized through conjugation prior to excretion; 80% to 90% of the dose appeared in the urine. The major metabolite was the O-conjugate of temazepam (90%); the O-conjugate of N-desmethyl temazepam was a minor metabolite (7%). Bioavailability, Induction, and Plasma Levels Following ingestion of a 30 mg temazepam capsule, measurable plasma concentrations were achieved 10 to 20 minutes after dosing with peak plasma levels ranging from 666 to 982 ng/mL (mean 865 ng/mL) occurring approximately 1.2 to 1.6 hours (mean 1.5 hours) after dosing. In a 7 day study, in which subjects were given a 30 mg temazepam capsule 1 hour before retiring, steady-state (as measured by the attainment of maximal trough concentrations) was achieved by the third dose. Mean plasma levels of temazepam (for days 2 to 7) were 260±210 ng/mL at 9 hours and 75±80 ng/mL at 24 hours after dosing. A slight trend toward declining 24 hour plasma levels was seen after day 4 in the study, however, the 24 hour plasma levels were quite variable. At a dose of 30 mg once-a-day for 8 weeks, no evidence of enzyme induction was found in man. Elimination Rate of Benzodiazepine Hypnotics and Profile of Common Untoward Effects The type and duration of hypnotic effects and the profile of unwanted effects during administration of benzodiazepine hypnotics may be influenced by the biologic half-life of the administered drug and for some hypnotics, the half-life of any active metabolites formed. Benzodiazepine hypnotics have a spectrum of half-lives from short (4 hours) to long (20 hours). When half-lives are long, drug (and for some drugs their active metabolites) may accumulate during periods of nightly administration and be associated with impairments of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced. In contrast, if half-lives are shorter, drug (and, where appropriate, its active metabolites) will be cleared before the next dose is ingested, and carry-over effects related to excessive sedation or CNS depression should be minimal or absent. However, during nightly use for an extended period, pharmacodynamic tolerance or adaptation to some effects of benzodiazepine hypnotics may develop. If the drug has a short elimination half-life, it is possible that a relative deficiency of the drug, or, if appropriate, its active metabolites (i.e., in relationship to the receptor site) may occur at some point in the interval between each night's use. This sequence of events may account for 2 clinical findings reported to occur after several weeks of nightly use of rapidly eliminated benzodiazepine hypnotics, namely, increased wakefulness during the last third of the night, and the appearance of increased signs of daytime anxiety. Controlled Trials Supporting Efficacy Temazepam improved sleep parameters in clinical studies. Residual medication effects (\"hangover\") were essentially absent. Early morning awakening, a particular problem in the geriatric patient, was significantly reduced. Patients with chronic insomnia were evaluated in 2 week, placebo controlled sleep laboratory studies with temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time and sleep latency, with significant drug-placebo differences at 2 weeks occurring only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose. In these sleep laboratory studies, REM sleep was essentially unchanged and slow wave sleep was decreased. No measurable effects on daytime alertness or performance occurred following temazepam treatment or during the withdrawal period, even though a transient sleep disturbance in some sleep parameters was observed following withdrawal of the higher doses. There was no evidence of tolerance development in the sleep laboratory parameters when patients were given temazepam nightly for at least 2 weeks. In addition, normal subjects with transient insomnia associated with first night adaptation to the sleep laboratory were evaluated in 24 hour, placebo controlled sleep laboratory studies with temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear doseresponse improvement in total sleep time, sleep latency and number of awakenings, with significant drug-placebo differences occurring for sleep latency at all doses, for total sleep time at the 2 higher doses and for number of awakenings only at the 30 mg dose." ], "indications_and_usage": [ "INDICATIONS AND USAGE Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.", "INDICATIONS FOR USE Sentra PM is intended for the clinical dietary management of the metabolic processes associated with sleep disorders." ], "set_id": "a4231f67-6c04-4ce6-8c3d-6db52afaadbe", "id": "73930acb-c116-402a-87db-f02222e3ff25", "pediatric_use": [ "Pediatric Use Safety and effectiveness in pediatric patients have not been established." ], "inactive_ingredient": [ "INGREDIENTS Name Type Strength Moiety UNII Preferred Substance temazepam Active 15 mg In 1 temazepam CHB1QD2QSS TEMAZEPAM starch, corn Inactive O8232NY3SJ STARCH, CORN anhydrous lactose Inactive 3SY5LH9PMK ANHYDROUS LACTOSE magnesium stearate Inactive 70097M6I30 MAGNESIUM STEARATE sodium lauryl sulfate Inactive 368GB5141J SODIUM LAURYL SULFATE FDandC BLUE NO. 1 Inactive H3R47K3TBD FDandC BLUE NO. 1 FDandC YELLOW NO. 5 Inactive I753WB2F1M FDandC YELLOW NO. 5 FDandC YELLOW NO. 6 Inactive H77VEI93A8 FDandC YELLOW NO. 6 gelatin Inactive 2G86QN327L GELATIN titanium dioxide Inactive 15FIX9V2JP TITANIUM DIOXIDE benzyl alcohol Inactive LKG8494WBH BENZYL ALCOHOL butylparaben Inactive 3QPI1U3FV8 BUTYLPARABEN sodium lauryl sulfate Inactive 368GB5141J SODIUM LAURYL SULFATE edetate calcium disodium Inactive 25IH6R4SGF EDETATE CALCIUM DISODIUM methylparaben Inactive A2I8C7HI9T METHYLPARABEN propylparaben Inactive Z8IX2SC1OH PROPYLPARABEN sodium propionate Inactive DK6Y9P42IN SODIUM PROPIONATE ammonia Inactive 5138Q19F1X AMMONIA alcohol Inactive 3K9958V90M ALCOHOL isopropyl alcohol Inactive ND2M416302 ISOPROPYL ALCOHOL butyl alcohol Inactive 8PJ61P6TS3 BUTYL ALCOHOL shellac Inactive 46N107B71O SHELLAC potassium hydroxide Inactive WZH3C48M4T POTASSIUM HYDROXIDE propylene glycol Inactive 6DC9Q167V3 PROPYLENE GLYCOL ferrosoferric oxide Inactive XM0M87F357 FERROSOFERRIC OXIDE" ], "contraindications": [ "CONTRAINDICATIONS Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatalpostnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common." ], "warnings": [ "WARNINGS Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia may be the consequence of an unrecognized psychiatric or physical disorder as may the emergence of new abnormalities of thinking or behavior. Such abnormalities have also been reported to occur in association with the use of drugs with central nervous system depressant activity, including those of the benzodiazepine class. Because some of the worrisome adverse effects of benzodiazepines, including temazepam, appear to be dose related (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ), it is important to use the lowest possible effective dose. Elderly patients are especially at risk. Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem out of character, similar to that seen with alcohol. Other kinds of behavioral changes can also occur, for example, bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as \"sleepdriving\" (i.e., driving while not fully awake after ingestion of a sedativehypnotic, with amnesia for the event) have been reported. These events can occur in sedativehypnoticnaive as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with temazepam alone at therapeutic doses, the use of alcohol and other CNS depressants with temazepam appears to increase the risk of such behaviors, as does the use of temazepam at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of temazepam should be strongly considered for patients who report a \"sleep-driving\" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleepdriving, patients usually do not remember these events. Amnesia and other neuro-psychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking has been reported in association with the use of sedative/hypnotics. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Withdrawal symptoms (of the barbiturate type) have occurred after the abrupt discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE ). Severe Anaphylactic and Anaphylactoid Reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with temazepam should not be rechallenged with the drug." ], "pregnancy": [ "Pregnancy Pregnancy Category X (see CONTRAINDICATIONS )." ], "nursing_mothers": [ "Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when temazepam is administered to a nursing woman." ], "microbiology": [ "PHYSICIAN THERAPEUTICS SENTRA PM Medical Food Rx only 60 Capsules Directions for use: Must be administered under medical supervision. For adults only. As a Medical Food, take two (2) capsules at bedtime or as directed by your medical practitioner. For the dietary management of sleep disorders. Contains no added sugar, starch, wheat, yeast, preservatives, artificial color or flavor. Storage: Keep tightly closed in a cool dry place 8-320 C (45-900F), relative humidity, below 50%. Warning: Keep this product out of the reach of children. NDC# 68405-1003-02 Ingredients: Each serving (2 capsules) contains: Proprietary Amino Acid blend Choline Bitartrate, Glutamic Acid (L-Glutamic Acid), Cocoa Extract (fruit), Proprietary Herbal Blend Ginkgo Biloba (leaves), Griffonia Seed Extract (5-HTP), Hawthorn Berry (fruit), Acetyl L-Carnitine HCl, Dextrose Other Ingredients: Gelatin, Cellulose, Dicalcium Phosphate, Silicon Dioxide and Vegetable Magnesium Stearate. Distributed by: Physician Therapeutics LLC, Los Angeles, CA 90077 www.ptlcentral.com Patent Pending" ], "spl_product_data_elements": [ "Strazepam TEMAZEPAM, CHOLINE TEMAZEPAM TEMAZEPAM TEMAZEPAM TEMAZEPAM STARCH, CORN ANHYDROUS LACTOSE MAGNESIUM STEARATE SODIUM LAURYL SULFATE FD&C BLUE NO. 1 FD&C YELLOW NO. 6 GELATIN TITANIUM DIOXIDE SODIUM LAURYL SULFATE AMMONIA ALCOHOL ISOPROPYL ALCOHOL BUTYL ALCOHOL SHELLAC POTASSIUM HYDROXIDE PROPYLENE GLYCOL FERROSOFERRIC OXIDE Blue opaque cap and white opaque body 15mg;Novel121 Sentra PM 60 CHOLINE CHOLINE CHOLINE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN GELATIN RED ;" ], "adverse_reactions_table": [ "
Temazepam % Incidence (n=1076) Placebo % Incidence (n=783)
Drowsiness 9.1 5.6
Headache 8.5 9.1
Fatigue 4.8 4.7
Nervousness 4.6 8.2
Lethargy 4.5 3.4
Dizziness 4.5 3.3
Nausea 3.1 3.8
Hangover 2.5 1.1
Anxiety 2.0 1.5
Depression 1.7 1.8
Dry Mouth 1.7 2.2
Diarrhea 1.7 1.1
Abdominal Discomfort 1.5 1.9
Euphoria 1.5 0.4
Weakness 1.4 0.9
Confusion 1.3 0.5
Blurred Vision 1.3 1.3
Nightmares 1.2 1.7
Vertigo 1.2 0.8
" ], "openfda": {}, "controlled_substance": [ "Controlled Substance Temazepam is a controlled substance in Schedule IV." ], "version": "17", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.", "DOSAGE AND ADMINISTRATION Recommended Administration For the dietary management of the metabolic processes associated with sleep disorders. Take (2) capsules daily at bedtime. An additional dose of one or two capsules may be taken after awakenings during the night. As with most amino acid formulations Sentra PM should be taken without food to increase the absorption of key ingredients." ], "adverse_reactions": [ "ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System - anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular - dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses - hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).", "ADVERSE REACTIONS Oral supplementation with L-tryptophan or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each Sentra PM capsule does not exceed 400 mg." ], "spl_unclassified_section": [ "Sentra PM™PRODUCT INFORMATION Sentra PM (U.S. patent pending) capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes of sleep disorders (SD). Must be administered under physician supervision. Medical Foods Medical Food products are often used in hospitals (e.g., for burn victims or kidney dialysis patients) and outside of a hospital setting under a physician’s care for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. Congress defined \"Medical Food\" in the Orphan Drug Act and Amendments of 1988 as \"a system which is formulated to be consumed or administered enterally [or orally] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.\" Medical Foods are complex formulated products, requiring sophisticated and exacting technology. Sentra PM has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. Sentra PM must be used while the patient is under the ongoing care of a physician. SLEEP DISORDERS (SD) SD as a Metabolic Deficiency Disease A critical component of the definition of a Medical Food is the requirement for a distinctive nutritional deficiency. FDA scientists have proposed a physiologic definition of a distinctive nutritional deficiency as follows: “the dietary management of patients with specific diseases requires, in some instances, the ability to meet nutritional requirements that differ substantially from the needs of healthy persons. For example, in establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine National Academy of Sciences, recognized that different or distinctive physiologic requirements may exist for certain persons with \"special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies. Thus, the distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism, and excretion.” It was also proposed that in patients with certain disease states who respond to nutritional therapies, a physiologic deficiency of the nutrient is assumed to exist. For example, if a patient with sleep disorders responds to a tryptophan formulation by improving the duration and quality of sleep, a deficiency of tryptophan is assumed to exist. Patients with sleep disorders are known to have nutritional deficiencies of tryptophan, choline, flavonoids, and certain antioxidants. Patients with sleep disorders frequently exhibit reduced plasma levels of tryptophan and have been shown to respond to oral administration of tryptophan or a 5-hydoxytryptophan formulation. Research has shown that tryptophan reduced diets result in a fall of circulating tryptophan. Patients with sleep disorders have activation of the tryptophan degradation pathway that increases the turnover of tryptophan leading to a reduced level of production of serotonin for a given tryptophan blood level. Research has also shown that a genetic predisposition can lead to increased tryptophan requirements in certain patients with sleep disorders. Choline is required to fully potentiate acetylcholine synthesis by brain neurons. A deficiency of choline leads to reduced acetylcholine production by the neurons. Low fat diets, frequently used by patients with sleep disorders, are usually choline deficient. Flavonoids potentiate the production of acetylcholine by the neurons thereby inducing REM sleep. Low fat diets and diets deficient in flavonoid rich foods result in inadequate flavonoid concentrations, impeding acetylcholine production in certain patients with sleep disorders. Provision of tryptophan, choline, and flavonoids with antioxidants, in specific proportions can restore the production of beneficial serotonin and acetylcholine, thereby improving sleep quality." ], "laboratory_tests": [ "Laboratory Test The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.", "Temazepam Outter" ], "how_supplied": [ "HOW SUPPLIED Temazepam Capsules USP 15 mg Green opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 100........NDC 67877-146-01 Bottle of 500........NDC 67877-146-05 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 100........NDC 67877-147-01 Bottle of 500........NDC 67877-147-05 Dispense in a well-closed, light-resistant container with a child-resistant closure. *Romazicon is the registered trademark of Hoffman-LaRoche Inc. **Trademark of Medical Economics Company, Inc. Manufactured by: Distributed by: Novel Laboratories, Inc. ASCEND Laboratories, LLC Somerset, NJ 08873 Montvale, NJ 07645", "How Supplied Sentra PM is supplied in red and white, size 0 capsules in bottles of 60 capsules. Physician Supervision Sentra PM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. Sentra PM is supplied to physicians in a recyclable plastic bottle with a child-resistant cap. U.S. patents pending. Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225 Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com © Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved NDC # 68405-1003-02" ], "information_for_patients": [ "Information for Patients The text of a patient Medication Guide is printed at the end of this insert. To assure safe and effective use of temazepam, the information and instructions provided in this patient Medication Guide should be discussed with patients. Special Concerns \"Sleep-Driving\" and Other Complex Behaviors - There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since \"sleep-driving\" can be dangerous. This behavior is more likely to occur when temazepam is taken with alcohol or other central nervous system depressants (see WARNINGS ). Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events." ], "package_label_principal_display_panel": [ "Packaged by Bryant Ranch North Hollywood CA 91605 Temazepam 15mg(CIV) Capsule Compare to Restore 15mg(CIV) Capsule MYLAN PHARMACEUTICALS NC #30 EXP 11/09 NDC 6362916192 NANA LOT 10973 Rx Only Do Not Drink Alcohol May Cause Drowsiness/No Alcohol", "A Convenience Packed Medical Food and Drug Strazepam PHYSICIAN THERAPEUTICS Sentra PM 60 Capsules Temazepam 15 mg 30 Capsules No Refills Without Physician Authorization Rx Only NDC# 68405-8013-06 of this co-pack For the Dietary Management of Sleep Disorders. Two capsules at bedtime or as directed by physician. See product label and insert. Sentra PM Medical Food As prescribed by physician. See product label and product information insert. Temazepam 15mg Rx Drug Physician Therapeutics LLC Los Angeles, CA 90077 on November 21, 2006", "Sentra PM Temazepam" ], "clinical_studies": [ "CLINICAL EXPERIENCE The administration of Sentra PM has demonstrated significant functional improvement in the quality and quantity of sleep when used for the dietary management of the metabolic processes associated with sleep disorders. Administration of Sentra PM results in the induction and maintenance of sleep in patients with sleep disorders. Sentra PM has no effect on normal blood pressure." ], "spl_medguide": [ "MEDICATION GUIDE TEMAZEPAM Capsules, USP C-IV (temazepam) Read the Medication Guide that comes with TEMAZEPAM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. ____________________________________________________________________ What is the most important information I should know about TEMAZEPAM? After taking TEMAZEPAM, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with TEMAZEPAM. Reported activities include: • driving a car (\"sleep-driving\") • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking TEMAZEPAM. Important: 1. Take TEMAZEPAM exactly as prescribed • Do not take more TEMAZEPAM than prescribed. • Take TEMAZEPAM right before you get in bed, not sooner. 2. Do not take TEMAZEPAM if you: • drink alcohol • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take TEMAZEPAM with your other medicines • cannot get a full night's sleep ____________________________________________________________________ What is TEMAZEPAM? TEMAZEPAM is a sedative-hypnotic (sleep) medicine. TEMAZEPAM is used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include: • trouble falling asleep • waking up often during the night TEMAZEPAM is not for children. TEMAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away TEMAZEPAM may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Who should not take TEMAZEPAM? Do not take TEMAZEPAM if you are pregnant or planning to become pregnant. TEMAZEPAM may cause birth defects or harm a fetus (unborn baby). TEMAZEPAM may not be right for you. Before starting TEMAZEPAM, tell your doctor about all of your health conditions, including if you: • have a history of depression, mental illness, or suicidal • have a history of drug or alcohol abuse or addiction • have kidney or liver disease • have a lung disease or breathing problems • are breastfeeding Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take TEMAZEPAM with other medicines that can make you sleepy. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine. How should I take TEMAZEPAM? • Take TEMAZEPAM exactly as prescribed. Do not take more TEMAZEPAM than prescribed for you. • Take TEMAZEPAM right before you get into bed. • Do not take TEMAZEPAM unless you are able to get a full night's sleep before you must be active again. • Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. • If you take too much TEMAZEPAM or overdose, call your doctor or poison control center right away, or get emergency treatment. What are the possible side effects of TEMAZEPAM? Possible serious side effects of TEMAZEPAM include: • getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See \"What is the most important information I should know about TEMAZEPAM?\") • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts. • memory loss • anxiety • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking TEMAZEPAM. Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using TEMAZEPAM. The most common side effects of TEMAZEPAM are: • drowsiness • headache • tiredness • nervousness • dizziness • nausea • \"hangover\" feeling the day after taking TEMAZEPAM You may still feel drowsy the next day after taking TEMAZEPAM. Do not drive or do other dangerous activities after taking TEMAZEPAM until you feel fully awake. You may have withdrawal symptoms if you stop taking TEMAZEPAM suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your doctor to check if you need to stop TEMAZEPAM slowly. These are not all the side effects of TEMAZEPAM. Ask your doctor or pharmacist for more information. How should I store TEMAZEPAM? • Store TEMAZEPAM at room temperature, 68° to 77°F (20° to 25°C). • Keep TEMAZEPAM and all medicines out of reach of children. General Information about TEMAZEPAM Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TEMAZEPAM for a condition for which it was not prescribed. Do not share TEMAZEPAM with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law. This Medication Guide summarizes the most important information about TEMAZEPAM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TEMAZEPAM that is written for healthcare professionals. What are the ingredients in TEMAZEPAM? TEMAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away TEMAZEPAM may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. 15mg and 30mg Capsules Active Ingredient: temazepam USP 15 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FDandC Blue #1, FDandC yellow # 5, FDandC yellow # 6, gelatin and titanium dioxide. May also include: benzyl alcohol ,butylparaben, sodium lauryl sulfate, edetate calcium disodium, methylparaben, propyl paraben and sodium propionate. Imprinting ink may contain ammonium hydroxide, ethanol, 2-propanol, butanol, pharmaceutical shellac, potassium hydroxide, propylene glycol, black iron oxide, and other ingredents. 30 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: benzyl alcohol ,butylparaben, sodium lauryl sulfate, edetate calcium disodium, methylparaben, propyl paraben and sodium propionate. Imprinting ink may contain ammonium hydroxide, ethanol, 2-propanol, butanol, pharmaceutical shellac, potassium hydroxide, propylene glycol, black iron oxide, and other ingredents. Manufactured by: Novel Laboratories, Inc Somerset, NJ 08873 Distributed by: ASCEND Laboratories, LLC Montvale, NJ 07645 ALPI-147-05-00 Rev: 06/09 ASCEND Laboratories, LLC NDC 67877-146-01 TEMAZEPAM CIV Capsules, USP 15 mg Rx only 100 capsules" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Mechanism of Action Sentra PM acts by restoring and maintaining the balance of the neurotransmitters, serotonin and acetylcholine, that are associated with sleep disorders. Metabolism The amino acids in Sentra PM are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in Sentra PM. Circulating tryptophan and choline blood levels determine the production of serotonin and acetylcholine. Excretion Sentra PM is not an inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, or 3A4. These isoenzymes are principally responsible for 95% of all detoxification of drugs, with CYP3A4 being responsible for detoxification of roughly 50% of drugs. Amino acids do not appear to have an effect on drug metabolizing enzymes." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies were conducted in rats at dietary temazepam doses up to 160 mg/kg/day for 24 months and in mice at dietary doses of 160 mg/kg/day for 18 months. No evidence of carcinogenicity was observed although hyperplastic liver nodules were observed in female mice exposed to the highest dose. The clinical significance of this finding is not known. Fertility in male and female rats was not adversely affected by temazepam. No mutagenicity tests have been done with temazepam." ], "overdosage": [ "OVERDOSAGE Manifestations of acute overdosage of temazepam can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD50 of temazepam was 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits. Treatment If the patient is conscious, vomiting should be induced mechanically or with emetics. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension. Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicorn® )*, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use. Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk References®**", "OVERDOSE There is a negligible risk of overdose with Sentra PM as the total dosage of amino acids in a one month supply (60 capsules) is less than 24 grams. Overdose symptoms may include diarrhea, weakness, and nausea. POST-MARKETING SURVEILLANCE Post-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to Sentra PM flavonoid ingredients, including cinnamon, cocoa, and chocolate. The reactions were transient in nature and subsided within 24 hours." ], "inactive_ingredient_table": [ "
Name Type Strength Moiety UNII Preferred Substance
temazepam Active 15 mg In 1 temazepam CHB1QD2QSS TEMAZEPAM
starch, corn Inactive O8232NY3SJ STARCH, CORN
anhydrous lactose Inactive 3SY5LH9PMK ANHYDROUS LACTOSE
magnesium stearate Inactive 70097M6I30 MAGNESIUM STEARATE
sodium lauryl sulfate Inactive 368GB5141J SODIUM LAURYL SULFATE
FDandC BLUE NO. 1 Inactive H3R47K3TBD FDandC BLUE NO. 1
FDandC YELLOW NO. 5 Inactive I753WB2F1M FDandC YELLOW NO. 5
FDandC YELLOW NO. 6 Inactive H77VEI93A8 FDandC YELLOW NO. 6
gelatin Inactive 2G86QN327L GELATIN
titanium dioxide Inactive 15FIX9V2JP TITANIUM DIOXIDE
benzyl alcohol Inactive LKG8494WBH BENZYL ALCOHOL
butylparaben Inactive 3QPI1U3FV8 BUTYLPARABEN
sodium lauryl sulfate Inactive 368GB5141J SODIUM LAURYL SULFATE
edetate calcium disodium Inactive 25IH6R4SGF EDETATE CALCIUM DISODIUM
methylparaben Inactive A2I8C7HI9T METHYLPARABEN
propylparaben Inactive Z8IX2SC1OH PROPYLPARABEN
sodium propionate Inactive DK6Y9P42IN SODIUM PROPIONATE
ammonia Inactive 5138Q19F1X AMMONIA
alcohol Inactive 3K9958V90M ALCOHOL
isopropyl alcohol Inactive ND2M416302 ISOPROPYL ALCOHOL
butyl alcohol Inactive 8PJ61P6TS3 BUTYL ALCOHOL
shellac Inactive 46N107B71O SHELLAC
potassium hydroxide Inactive WZH3C48M4T POTASSIUM HYDROXIDE
propylene glycol Inactive 6DC9Q167V3 PROPYLENE GLYCOL
ferrosoferric oxide Inactive XM0M87F357 FERROSOFERRIC OXIDE
" ] }, { "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": "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": "20130422", "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous lactose*, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, isopropyl alcohol*, kaolin, lake brilliant blue FCF*, magnesium stearate, maltodextrin*, microcrystalline cellulose, Opacode black S-1-17823*, opagloss 6000P*, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, tartaric acid*, titanium dioxide. *contains one or more of these ingredients" ], "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 when abdominal pain, nausea, or vomiting are present for longer than 1 week, unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health care 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": [ "Laxative maximum strength Sennosides SENNOSIDES SENNOSIDES ACACIA CALCIUM SULFATE ANHYDROUS CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE FD&C BLUE NO. 1 FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW KAOLIN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SHELLAC SODIUM LAURYL SULFATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE ANHYDROUS LACTOSE ISOPROPYL ALCOHOL MALTODEXTRIN TARTARIC ACID TCL083;S25" ], "ask_doctor": [ "Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions adults and children 12 years of age and older take 2 tablets once or twice daily with a glass of water children 6 to under 12 years of age take 1 tablet once or twice daily with a glass of water children under 6 years of age consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "spl_unclassified_section": [ "DRUG FACTS" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use. These may be signs of a serious condition." ], "storage_and_handling": [ "Other information each tablet contains: calcium 40 mg/ tablet each tablet contains: magnesium 10 mg/ tablet each tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM store at 15º - 30º C (59º-86º F) keep in a dry place do not expose to excessive heat" ], "do_not_use": [ "Do not use when abdominal pain, nausea, or vomiting are present for longer than 1 week, unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to maximum strength EX-LAX® active ingredient † Maximum Strength Laxative Sennosides USP, 25 mg stimulant laxative dependable overnight relief TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION † This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Ex-Lax®", "Product Label Sennosides 25 mg Equaline Laxative maximum strength" ], "indications_and_usage": [ "Uses relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours." ], "set_id": "bbce0117-2a71-45d3-b96b-3485f6078d06", "id": "0ec0a92e-5372-4a7f-a06f-561779a4f816", "active_ingredient": [ "Active ingredient (in each tablet) Sennosides USP, 25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and older take 2 tablets once or twice daily with a glass of water
children 6 to under 12 years of age take 1 tablet once or twice daily with a glass of water
children under 6 years of age consult a doctor
" ] }, { "effective_time": "20120821", "inactive_ingredient": [ "Inactive ingredients *acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate. *May also contain." ], "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 asthma(wheezing) shock 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 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 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 asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes 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 allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area 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? 1-800-632-6900" ], "spl_product_data_elements": [ "Aspirin Enteric Safety Coated Aspirin ASPIRIN ASPIRIN DIACETYLATED MONOGLYCERIDES ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSES HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERRIC OXIDE YELLOW METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL 400 POLYSORBATE 80 POVIDONES PROPYLENE GLYCOL DIMETHICONE SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE ENTERIC COATED E;heart;81" ], "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 asthma" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age 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 of age: consult 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 vomit blood have bloody or black stools have stomach pain that does not get better allergic reaction occurs ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear redness or swelling is present in the painful area" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) do not use if imprinted safety seal under cap is broken or missing †Bayer® Aspirin is a trademark of Bayer Healthcare LLC (Morristown,NJ 07960). Bayer Healthcare LLC is not affiliated with The Kroger Co. or this product." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "Principal Display Panel KROGER® Delayed Release Pain Reliever (NSAID)* Aspirin 81 mg ADULT LOW DOSE Aspirin Regimen ENTERIC SAFETY- COATED TABLETS Compare to Aspirin Regimen BAYER® 81 mg active ingredient ®† SEE NEW WARNINGS INFORMATION", "Product Label Aspirin 81 mg kroger aspirin 81 mg enteric coated" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief." ], "set_id": "c321f730-a90b-4a5b-8567-efffb4dfbbae", "id": "b32b49ec-540e-4f5d-923a-a9f547d9919a", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood) gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81mg (NSAID)* *nonsteroidal anti- inflammatory drug" ] }, { "effective_time": "20130122", "precautions": [ "PRECAUTIONS: GENERAL Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension. Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur." ], "spl_patient_package_insert": [ "Patient Insert DONNATAL® TABLETS Rx Only Rev. 06/07" ], "description": [ "DESCRIPTION: Each Donnatal® Tablet contains: Phenobarbital, USP .....................................................16.2 mg Hyoscyamine Sulfate, USP .............................................0.1037 mg Atropine Sulfate, USP.....................................................0.0194 mg Scopolamine Hydrobromide, USP .................................0.0065 mg" ], "indications_and_usage": [ "INDICATIONS AND USAGE Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS." ], "set_id": "c8595e5b-3a16-420a-b9ea-36051b255fed", "id": "4898c310-8e06-4a86-9d4d-822cadd2e27d", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Anhydrous Lactose, Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose." ], "contraindications": [ "CONTRAINDICATIONS: Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic mega-colon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. Donnatal® is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement." ], "warnings": [ "WARNINGS: In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Donnatal® may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs. Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction." ], "pregnancy": [ "PREGNANCY: PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with Donnatal®. It is not known whether Donnatal® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® should be given to a pregnant woman only if clearly needed." ], "nursing_mothers": [ "NURSING MOTHERS. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® is administered to a nursing woman." ], "spl_product_data_elements": [ "Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Phenobarbital Phenobarbital HYOSCYAMINE SULFATE HYOSCYAMINE ATROPINE SULFATE ATROPINE SCOPOLAMINE HYDROBROMIDE SCOPOLAMINE ANHYDROUS LACTOSE CALCIUM STEARATE SILICON DIOXIDE STARCH, CORN CELLULOSE, MICROCRYSTALLINE D-shaped tablet D;Donnatal" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a minimum of adverse effects. Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity of symptoms." ], "adverse_reactions": [ "ADVERSE REACTIONS: Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbituates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angiodema and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions." ], "spl_unclassified_section": [ "Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942 Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised June 2007 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "how_supplied": [ "Donnatal® Tablets are supplied as: White, D-shaped tablets debossed “D” on one side and “Donnatal” on the other side. Bottles of 100 tablets NDC 54868-1237-1 AVOID FREEZING Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser." ], "package_label_principal_display_panel": [ "NDC 54868-1237-1 100 Tablets Donnatal® Each tablet contains: Hyoscyamine Sulfate, USP . . . . 0.1037 mg Atropine Sulfate, USP . . . . . . . 0.0194 mg Scopolamine HBr, USP . . . . . . 0.0065 mg Phenobarbital, USP . . . . . . . . . 16.2 mg RX only Usual Adult Usage: See accompanying product literature for complete information. U425-10-3 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure. Label for Donnatal 100 tablet bottle" ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY: This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential." ], "overdosage": [ "OVERDOSAGE: The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be used." ] }, { "effective_time": "20131213", "inactive_ingredient": [ "Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide" ], "purpose": [ "Purpose 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" ], "when_using": [ "When using this product do not take dose within one hour of taking an antacid or milk you may experience abdominal discomfort, faintness and cramps" ], "questions": [ "Questions or comments? call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880" ], "spl_product_data_elements": [ "Enteric Coated Stimulant Laxative Bisacodyl BISACODYL BISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 Polyvinyl Acetate Phthalate POVIDONES SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TCL;003" ], "ask_doctor": [ "Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions DO NOT CHEW TABLETS adults and children 12 years and over: 1-3 tablets once daily children 6 to 11 years: 1 tablet once daily children under 6 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 you have rectal bleeding you fail to have a bowel movement after use of this product These may indicate a serious condition." ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "do_not_use": [ "Do not use for longer than one week when abdominal pain, nausea or vomiting are present in children under 6 years of age in persons who cannot swallow without chewing" ], "package_label_principal_display_panel": [ "IMAGE LABEL" ], "indications_and_usage": [ "Uses relieves occasional constipation generally produces bowel movement in 6-12 hours" ], "set_id": "c96e2eff-bd7e-4019-9826-c15bafe2e406", "id": "78f88be7-cf2a-457c-b2ab-3a9144283384", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work." ], "active_ingredient": [ "Active ingredient (in each tablet) Bisacodyl 5 mg" ] }, { "effective_time": "20121023", "purpose": [ "PURPOSE Anti-diarrheal" ], "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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "questions": [ "QUESTIONS? Call 1800-406-7984" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding Ask a health professional before use." ], "indications_and_usage": [ "USE Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "set_id": "cb8de80f-8a28-4eb1-a431-01ff8f32d756", "id": "80a4c80a-d34f-48d8-8484-f605ad892a25", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Taking antibiotics" ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCI USP, 2 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor
" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "warnings": [ "WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use If you have bloody or black stool Ask a doctor before use if you have fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are Taking antibiotics When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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 (1-800-222-1222)." ], "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 TRISTEARIN MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, PREGELATINIZED CORN ANHYDROUS LACTOSE 123" ], "ask_doctor": [ "Ask a doctor before use if you have fever mucus in the stool a history of liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition." ], "spl_unclassified_section": [ "OTHER INFORMATION store between 20 ° – 25 ° C (68 ° – 77 ° F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE." ], "do_not_use": [ "Do not use If you have bloody or black stool" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL GOOD NEIGHBOR PHARMACY ® NDC 46122-0169-08 * Compare to Imodium * A-D active ingredient Loperamide HCl Tablets USP, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea 72 caplets ٭ Each caplet ( ٭ capsule-shaped tablet) contains Loperamide HCl USP, 2 mg Distributed By: AmerisourceBergen 5098330/R0912 This is the bottle label for 72 count Good Neighbor Pharmacy Loperamide HCl tablets USP, 2 mg." ] }, { "effective_time": "20091118", "inactive_ingredient": [ "Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate." ], "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." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 take more than directed. Taking more than directed may cause drowsiness." ], "questions": [ "Questions or comments? call 1-877-446-3679 Mylan Pharmaceuticals Inc. Morgantown, WV 26505" ], "spl_product_data_elements": [ "Loratadine loratadine LORATADINE LORATADINE ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONES SODIUM LAURYL SULFATE white to off-white M;L;17" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 6 years and over 1 tablet daily; not 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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Other information • Tamper Evident: do not use if imprinted foil seal under cap is missing, open or broken. • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING NDC 0378-1925-01 Original Prescription Strength Non-Drowsy* Loratadine Tablets USP, 10 mg Antihistamine Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. 100 TABLETS RM1925A3 Loratadine Tablets 10 mg Bottle Front Layer Loratadine Tablets 10 mg Bottle Back of Front Layer Loratadine Tablets 10 mg Bottle Base Layer" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat" ], "set_id": "cd9f981a-0cdf-48ea-91b7-b5c25632e2c2", "id": "d1604be0-82cb-4570-a19b-3d25b3bbde14", "active_ingredient": [ "Active ingredient Loratadine USP, 10 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 tablet daily; not 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
" ] }, { "spl_product_data_elements": [ "Stomach Relief Anti Diarrheal LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE LACTOSE CROSCARMELLOSE SODIUM CROSPOVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN pea green 123 123" ], "active_ingredient": [ "ACTIVE INGREDIENT Loperamide HCl 2 mg" ], "purpose": [ "PURPOSE Anti Diarrheal" ], "dosage_and_administration": [ "DOSAGE Directions: • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise, use age.Adults and children 12 years and over: 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours. Children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours Children 6-8 years (48-59 lbs): 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours Children under 6 years (up to 47 lbs): ask a doctor" ], "indications_and_usage": [ "INDICATIONS & USAGE • controls the symptoms of diarrhea, including Travelers’ Diarrhea" ], "warnings": [ "WARNINGS Allergy Alert Do not use • if you have ever had a rash or other allergic reaction to loperamide HCI • if you have bloody or black stool Ask a doctor before use • if you have: • fever • mucus in stool • a history of liver disease Ask a doctor or pharmacist before use • if you are: • taking antibiotics When using this product: • tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if : • symptoms get worse • diarrhea lasts for more than 2 days • you get abdominal swelling or bulging. These may be signs of a serious condition" ], "pregnancy_or_breast_feeding": [ "PREGNANCY If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, DC yellow no. 10, FDC blue no. 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "package_label_principal_display_panel": [ "LABEL DISPLAY PANEL MM1 Stomach Relief packet" ], "set_id": "de26457a-55a6-4fad-96d9-04697e157c09", "id": "21a6698d-3c80-4dfa-98d9-afd5546822b4", "effective_time": "20121015", "version": "2", "openfda": {} }, { "effective_time": "20151022", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide." ], "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." ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)" ], "questions": [ "Questions or comments? Call 1-888-588-1418 CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2015 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-32583" ], "spl_product_data_elements": [ "Fexofenadine HCl Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE ANHYDROUS LACTOSE COLLOIDAL SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSES POLYETHYLENE GLYCOLS FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW SG;202" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease 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 an allergic reaction to this product occurs. Seek medical help right away." ], "spl_unclassified_section": [ "Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened. store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 8.2 mg this product meets the requirements of USP Dissolution Test 2" ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "package_label_principal_display_panel": [ "CVS Health-Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets* Allergy Relief - 24 HOUR FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg Antihistamine Indoor & Outdoor Allergies 180mg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "e7c4a402-09ca-4f95-86fa-20b6117facb3", "id": "b9bd6779-8514-49a7-afc2-ed767377fdfb", "active_ingredient": [ "ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP, 180 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
" ] }, { "effective_time": "20110110", "inactive_ingredient": [ "INACTIVE INGREDIENT Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate. ." ], "purpose": [ "OTC - PURPOSE Pain reliever." ], "keep_out_of_reach_of_children": [ "OTC - 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, asthma (wheezing), 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." ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN LACTOSE CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE RED METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE DIMETHICONE POLYSORBATE 80 SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE heart" ], "ask_doctor": [ "OTC - ASK 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 asthma." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Drink with 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 Consult a doctor OTHER INFORMATION Store at 15°-30°C (59°-86°F). Do not use if imprinted seal under cap is missing or damaged." ], "pregnancy_or_breast_feeding": [ "OTC - PREGNANCY 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": [ "OTC - 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, allergic reaction occurs seek medical help right away, pain gets worse or lasts more than 10 days, redness or swelling is present, new symptoms occur, ringing in the ears or loss of hearing occurs." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5fdaba26-figure-01" ], "indications_and_usage": [ "INDICATIONS AND USAGE For temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief." ], "set_id": "eae5797a-0f4d-4b80-bd48-2445c2b74b25", "id": "5fdaba26-4c64-4896-a89a-69fefec6e563", "ask_doctor_or_pharmacist": [ "OTC - ASK DOCTOR/PHARMACIST Before use if you are taking a prescription drug for : gout diabetes arthritis" ], "active_ingredient": [ "OTC - ACTIVE INGREDIENT Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drug" ], "dosage_and_administration_table": [ "
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 Consult a doctor
" ] }, { "effective_time": "20110209", "inactive_ingredient": [ "Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, 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 are taking a diuretic you have asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition 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 ringing in the ears or a 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. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? call 1-888-838-2872, weekdays, 8 AM-5 PM ET" ], "spl_product_data_elements": [ "Aspirin EC Aspirin Aspirin Aspirin anhydrous lactose carnauba wax silicon dioxide croscarmellose sodium D&C Yellow NO. 10 aluminum oxide cellulose, microcrystalline polysorbate 80 sodium hydroxide sodium lauryl sulfate talc titanium dioxide triethyl citrate Bi-convex" ], "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 asthma you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea" ], "openfda": {}, "version": "1", "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: consult 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", "Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960 Dist. 1993 0810REV 89 387R Repackaged by: REBEL DISTRIBUTORS CORP , Thousand Oaks, CA 91320 TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING ** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer ® Low Dose." ], "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 ringing in the ears or a loss of hearing occurs" ], "storage_and_handling": [ "Other information store at 25°C (77°F) excursions permitted between 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 - 81 mg Bottle Label Aspirin EC 81mg" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur" ], "set_id": "ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b", "id": "ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug under a doctor's care for any serious condition" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 81 mg (NSAID nonsteroidal anti-inflammatory drug )" ] }, { "effective_time": "20131023", "inactive_ingredient": [ "Inactive Ingredients Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate." ], "purpose": [ "Purpose Pain Relief" ], "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) Shock Facial Swelling 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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product takes 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: The stomach bleeding warning applies to you You have 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 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 pain gets worse or lasts more than 10 days New symptoms occur redness or swelling is present ringing in the ears or a loss of hearing occurs These could be signs of serious conditions. 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." ], "questions": [ "Questions? Call 1-855-314-1850 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Velocity Pharma LLC" ], "spl_product_data_elements": [ "Aspirin Aspirin ASPIRIN ASPIRIN CARNAUBA WAX ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 BROWN IRON OXIDE METHACRYLIC ACID CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 DIMETHICONE SODIUM HYDROXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE A" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and Children 12 years and over: For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor. Children under 12 years of age: Do not use unless directed by a doctor." ], "spl_unclassified_section": [ "Other Information Store at a controlled temperature between 62 and 77 degrees F" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 76168-009-10 –60 COUNT Enteric Coated to help prevent upset stomach 5a83ea7c-figure-01 5a83ea7c-figure-02" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains" ], "set_id": "f815feab-5e8c-40a9-b241-1ac1c0ffa50d", "id": "5a83ea7c-214c-4a89-9e10-dede03f58db3", "active_ingredient": [ "Active Ingredient (in each tablet) Aspirin 81 mg (NSAID)" ] } ] }