{ "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": "2026-08-07", "results": { "skip": 0, "limit": 100, "total": 640 } }, "results": [ { "effective_time": "20151104", "inactive_ingredient": [ "INACTIVE INGREDIENT SECTION FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special" ], "purpose": [ "OTC - PURPOSE SECTION Stool softener" ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN SECTION In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS SECTION" ], "spl_product_data_elements": [ "Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 WATER SORBITOL Reddish SCU1" ], "ask_doctor": [ "OTC - ASK DOCTOR SECTION stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "other_safety_information": [ "OTHER SAFETY INFORMATION each softgel contains: sodium 5 mg VERY LOW SODIUM store at 15°-30°C (59°-86°F) keep tightly closed You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION SECTION doses may be taken as a single daily dose or in divided doses" ], "pregnancy_or_breast_feeding": [ "OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "OTC - STOP USE SECTION you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "SPL UNCLASSIFIED SECTION Manufactured for: QUALITEST PHARMACEUTICALS HUNTSVILLE, AL 35811 R0 07/2011 015021CPR" ], "do_not_use": [ "OTC - DO NOT USE SECTION Do not use if you are presently taking mineral oil, unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL image description" ], "indications_and_usage": [ "INDICATIONS & USAGE SECTION relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "set_id": "014d2ea7-e704-477a-8616-6bce2d9ea162", "id": "cdb61bfd-f6e7-454f-86d6-6049e0c2e95c", "active_ingredient": [ "OTC - ACTIVE INGREDIENT SECTION Docusate sodium 100 mg" ] }, { "effective_time": "20130424", "inactive_ingredient": [ "Inactive ingredients corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special." ], "purpose": [ "Purpose Stool softener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are currently taking mineral oil, unless directed by a doctor 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 could be signs of s 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? 1-800-645-2158" ], "spl_product_data_elements": [ "Stool Softener DC Laxative DOCUSATE CALCIUM DOCUSATE CALCIUM DOCUSATE CORN OIL D&C RED NO. 33 FD&C RED NO. 40 GELATIN GLYCERIN WATER SORBITOL RED P58 OVAL" ], "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": "1", "dosage_and_administration": [ "Directions adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor children under 12 years of age : take as directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care 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 These could be signs of s serious condition." ], "storage_and_handling": [ "Other information store between 15º-30ºC (59º-86ºF)" ], "do_not_use": [ "Do not use if you are currently taking mineral oil, unless directed by a doctor 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 active ingredient in SURFAK®* Safe, Effective, Non-Habit Forming Stool Softener Laxative DC Docusate Calcium USP, 240 mg SOFTGEL CAPSULES TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *Rugby Laboratories is not affiliated with the owner of the trademark Surfak®. Distributed by: Atlantic Biologicals Corp Miami, Fl 33179 image description" ], "indications_and_usage": [ "Uses for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "0174e485-a3b3-4e42-9619-2c063d122417", "id": "32e3b0cb-965a-40f0-b0ce-931b61805e75", "active_ingredient": [ "Active ingredient (in each softgel) Docusate Calcium 240 mg Purpose Stool softener" ] }, { "effective_time": "20100726", "inactive_ingredient": [ "Inactive ingredients PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water" ], "purpose": [ "Purpose Nighttime Sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . In case of overdose,get medical help or contact a poison control center right away." ], "warnings": [ "Warnings Do not use for children under 12 years of age with any other product containing Diphenhydramine, even one used on skin Ask a doctor before use if you have Glaucoma trouble urinating due to enlarged postage gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks Stop use and ask doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 avoid alcoholic drinks" ], "spl_product_data_elements": [ "DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL GELATIN SORBITOL WATER FD&C BLUE NO. 1 293" ], "ask_doctor": [ "Ask a doctor before use if you have Glaucoma trouble urinating due to enlarged postage gland a breathing problem such as emphysema or chronic bronchitis" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Direction adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness." ], "do_not_use": [ "Do not use for children under 12 years of age with any other product containing Diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label Diphenhydramine Hydrochloride Soft Gelatin Capsules Each soft gelatin capsule contains: Diphenhydramine Hydrochloride USP 50 mg LOT NO : MFG DATE : EXP. DATE : NDC NO : 68210-1510-4 QUANTITY : 1000 × 4 Capsules GROSS WT. : WARNING: KEEP OUT OF REACH OF CHILDREN STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER. MANUFACTURED BY: Marksans Pharma Ltd VERNA, GOA-403722, INDIA. CODE : GO/DRUGS/515 MANUFACTURED FOR: SPIRIT PHARMACEUTICALS LLC 225 LINCOLN HWY, STE 205 FAIRLESS HILLS, PA 19030 PH.# 215 943 4000 FAX.# 215 943 4039 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" OLIL058 PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label" ], "indications_and_usage": [ "Uses For relief occasional sleeplessness" ], "set_id": "01ba06dd-fe81-465b-ad53-cdccde45f8e2", "id": "76d8de20-70b3-4727-9dea-d31d1b1e970d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each LiquiCap) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20130419", "inactive_ingredient": [ "Inactive Ingredients edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special." ], "purpose": [ "Purpose Stool softener" ], "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 abdominal pain, nausea or vomiting are present Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks you are presently taking mineral oil Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition you need to use a laxative for more than 1 week 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 1-877-932-7948" ], "spl_product_data_elements": [ "Stool Softener easy and gentle DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL P51" ], "ask_doctor": [ "Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks you are presently taking mineral oil" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition you need to use a laxative for more than 1 week" ], "storage_and_handling": [ "Other information each softgel contains: sodium 6 mg store at controlled room temperature 15 o - 30 o C (59 o - 86 o F)" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Dulcolax® Stool Softener* easy & gentle stool softener Docusate sodium 100 mg fast, dependable relief of occasional constipation predictable releif easy to swallow softgels safe & effective without harsh laxatives DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION . *This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare owner of the registered trademark of Dulcolax®", "Product Label Docusate Sodium 100 mg softgels Equaline" ], "indications_and_usage": [ "Uses temporary relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "022675f6-3e96-45fd-afe3-33f8a9db0b35", "id": "797007c5-3846-4302-b2a8-86734faf4fe4", "active_ingredient": [ "Active Ingredient (in each softgel) Docusate Sodium 100 mg Purpose Stool softener" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 softgel daily
children under 2 years of age ask a doctor
" ] }, { "effective_time": "20121213", "inactive_ingredient": [ "Inactive ingredients FD&C yellow no. 6, gelatin, glycerin, white edible ink" ], "purpose": [ "Purpose Anti-gas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Stop use and ask a doctor if condition persists Keep out of reach of children." ], "questions": [ "Questions? call toll-free 1-866-255-5204 (English/Spanish) weekdays" ], "spl_product_data_elements": [ "PHAZYME simethicone DIMETHICONE 410 DIMETHICONE 410 SILICON DIOXIDE FD&C YELLOW NO. 6 GELATIN GLYCERIN PZ;180" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • swallow one or two softgels as needed after a meal • do not exceed two softgels per day except under the advice and supervision of a physician" ], "stop_use": [ "Stop use and ask a doctor if condition persists" ], "storage_and_handling": [ "Other information • store at room temperature 59° - 86° F (15°- 30°C)" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0135-0429-09 Phazyme ® ANTI-GAS/ SIMETHICONE 180mg ULTRA STRENGTH STRONGEST DOSE AVAILABLE! RELIEVES GAS FAST • Pressure • Bloating • Discomfort Goes to Work in Minutes 60 SOFTGELS (180mg) Easy to Swallow • Has the highest dose of simethicone available • Goes to work in minutes • Contains a powerful ingredient, simethicone, the anti-gas medicine recommended most by physicians & pharmacists for relief of gas Serious medicine for serious gas! ® TAMPER EVIDENT PACKAGE - Do not use if seal under cap imprinted \"SEALED FOR YOUR PROTECTION\" is broken or missing or if \"PZ 180\" is missing from the softgel. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2011 GlaxoSmithKline PHAZYME® and other elements are registered trademarks of the GlaxoSmithKline group of companies. www.phazyme.com 28510XD Phazyme Carton" ], "indications_and_usage": [ "Use • relieves bloating, pressure or fullness commonly referred to as gas" ], "set_id": "0283fe56-526b-4380-9bfa-36076060d9ab", "id": "1c9187f4-b6cb-418c-a270-34e36be44d56", "active_ingredient": [ "Active ingredient (in each softgel ) Simethicone 180 mg" ] }, { "effective_time": "20130808", "inactive_ingredient": [ "Inactive Ingredients FD&C Blue #1, FD&C Red #40, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide. *Major Extra Strength Mapap is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®. Distributed by: MAJOR PHARMACEUTICALS Livonia, MI 48150 USA This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States They are supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0822-1 500 mg 30 Capsules in a Blister Pack RED 0904-1987" ], "purpose": [ "Purposes Analgesic, Antipyretic" ], "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 In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product" ], "spl_product_data_elements": [ "MAPAP Extra Strength Acetaminophen ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN POVIDONE K30 STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE CPC;617" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years of age and over take 2 capsules every 4 hour to 6 hours, not to exceed 8 capsules in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years of age Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause liver damage. DO NOT EXCEED RECOMMENDED DOSE Other information store at room temperature, USP use by expiration date on pckage do not use if capsule band or imprinted safety seal under cap is broken or missing side effects occur You may report side effects at 1-800-616-2471 (Toll Free)" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Mapap Extra Strength Capsules" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to the common cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "02f8cd87-ba7c-4314-9475-8a5b72c60545", "id": "41c99d5e-a695-4aba-8131-6104068368c5", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are taking the blood thinning drug warfarin" ], "inactive_ingredient_table": [ "
NDC Strength Quantity/Form Color Source Prod. Code
53808-0822-1 500 mg 30 Capsules in a Blister Pack RED 0904-1987
" ], "active_ingredient": [ "Active Ingredient (in each capsule) Acetaminophen 500 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take 2 capsules every 4 hour to 6 hours, not to exceed 8 capsules in 24 hours. Do not take for more than 10 days unless directed by a doctor.
children under 12 years of age Do not use Extra Strength product in children 12 years of age; this will provide more than the recommended dose (overdose) of pain reliever and could cause liver damage.
" ] }, { "effective_time": "20121217", "inactive_ingredient": [ "Inactive ingredients FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments? Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN FD&C BLUE NO. 1 GELATIN POLYETHYLENE GLYCOLS POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL IB200" ], "ask_doctor": [ "Ask a doctor before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma you are taking a diuretic" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear" ], "spl_unclassified_section": [ "Other information each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery" ], "package_label_principal_display_panel": [ "Principal Display Panel †COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS® Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)* Gluten Free Softgels** (**Liquid Filled Capsules) †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Liqui-Gels®. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Do not use if tamper-evident seal under bottle cap imprinted with \"SEALED for YOUR PROTECTION\" is broken or missing. Packaged by: PL Developments 200 Hicks Street Westbury, NY 11590, USA ©2012 Shopko Stores Operating Co., LLC", "Package Label Shopko Ibuprofen Capsules, 200 mg Ibuprofen, 200 mg" ], "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": "035db1ab-0c4d-4465-a71d-5e9cf228aa1a", "id": "5b630b51-cb5c-4f12-ad57-c54bd8d4b30f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20121103", "inactive_ingredient": [ "Inactive ingredients FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol" ], "purpose": [ "Purpose Pain reliever/ fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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 Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed" ], "questions": [ "Questions or comments ? Call toll free 1-877-932-7948" ], "spl_product_data_elements": [ "Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN FD&C BLUE NO. 1 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM HYDROXIDE WATER SORBITOL SORBITAN IB200" ], "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" ], "other_safety_information": [ "Other information each capsule contains : potassium 20 mg read all warnings and directions before use. Keep carton store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light. do not use if Tamper- Evident seal under bottle cap imprinted with \"Sealed for your protection\" is broken or missing † This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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": [ "Principal Display Panel Ibuprofen Capsules, 200 mg Pain reliever/ fever reducer (NSAID) 40 Softgels** (liquid filled capsules**) Compare to Advil® active ingredient † SEE NEW WARNINGS INFORMATION KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION Distributed by SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA PRODUCT OF USA Contact us at 1-877-932-7948 or www.supervalu-ourownbrands.com", "Product Label Ibuprofen capsules 200 mg Equaline Supervalu Ibuprofen 200 mg softgels" ], "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": "0397fd80-5af0-47d2-9042-236460cfaab5", "id": "54d70ebe-040f-488e-9a8f-2a9e67cb5dfa", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug" ], "active_ingredient": [ "Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20110708", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Glycerin, Xanthan Gum, Acacia Senegal Gum, Gelatin, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Sugar Lemon Fizz Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "03aa3c47-f615-4a4a-a418-5e09811c88fa", "id": "1f03db09-6859-4224-8687-7fc2e6ab9955", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20150727", "inactive_ingredient": [ "Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible ink" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you don't know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SORBITOL FD&C YELLOW NO. 6 FD&C RED NO. 40 WATER PROPYLENE GLYCOL POLYETHYLENE GLYCOLS POVIDONES Transparent 95A" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) do not take more than 4 doses per 24 hours adults and children 12 years and over: take 2 liquid caps with water every 6 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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you don't know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal display panel exchange ✓select Compare To The Active Ingredients of Vicks® DayQuil® LiquiCaps®* Non-Drowsy DAYTIME Cold & Flu Relief MULTI-SYMPTOM Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl • Pain Reliever/Fever Reducer • Cough Suppressant • Nasal Decongestant 24 Liquid Caps TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Liquicaps®. 50844 REV0113D53408 PRODUCT OF CANADA \"SATISFACTION GUARANTEED OR YOUR MONEY BACK\" Manufactured For Your Military Exchanges Distributed by: LNK International, Inc. Hauppauge, NY 11788 1-800-426-9391 Exchange Select 44-534 Exchange Select 44-534" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation" ], "set_id": "049e8565-d095-440c-bbe5-577b60481d4e", "id": "76752c0a-52c3-4667-ad10-b7e5c7960a2d", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each liquid cap) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Glycerin, Fragrance (Parfum), Acacia Senegal Gum, Gelatin, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation or redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Cherry Blossom Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation or redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "04f5ec8e-c7b1-407d-9b67-4cbbc48c02ae", "id": "632ede82-1e45-4c04-aeda-c7b3cb8473ab", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20141010", "inactive_ingredient": [ "edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special." ], "purpose": [ "Purpose Stool Softener" ], "keep_out_of_reach_of_children": [ "" ], "warnings": [ "Do not use •if you are currently taking mineral oil, unless directed by a doctor •when abdominal pain, nausea, or vomiting are present •for more than 1 week, unless directed by a doctor." ], "spl_product_data_elements": [ "EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SORBITOL P20" ], "ask_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 could be signs of a serious condition." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "" ], "pregnancy_or_breast_feeding": [ "•ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away." ], "information_for_patients": [ "Directions: Adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor. Children under 12 years of age: take as directed by doctor. Other Information: each softgel contains: sodium 15 mg. Store between 15-30 C (59-86 F)" ], "package_label_principal_display_panel": [ "UD Blister Box Label" ], "indications_and_usage": [ "Uses: •for the prevention of dry, hard stools •for relief of occasional constipation •this product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "050c6139-344b-47d4-e054-00144ff88e88", "id": "050c6139-344c-47d4-e054-00144ff88e88", "active_ingredient": [ "Active Ingredient (in each softgel) Docusate Sodium 250 mg" ] }, { "effective_time": "20131029", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Berry Cool Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "2.6 oz PDP DegreeMSBerryCoolPDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "05ff6d73-1a42-45ed-8bd8-1399297312da", "id": "1bbe36c8-cdda-46d2-9d8d-1436cbd6822c", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20120409", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Glycerin, Triethanolamine, Polyethylene, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Passionfruit Coconut Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "066aabc2-3cb0-40ba-8d94-8c54f6586f67", "id": "5f33d470-0843-479c-9ad6-60814006eaa9", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20120306", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Glycerin, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Acacia Senegal Gum, Gelatin, Xanthan Gum, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Blue 1 (CI 42090), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Malibu Citrus Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "068ad480-6a3e-48fd-8061-96e49277af4c", "id": "d60b83df-e1ed-4a35-97f7-aaa53d9168ba", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20110708", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Butyrospermum Parkii (Shea) Butter, Panthenol, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Acacia Senegal Gum, Gelatin, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Ext. Violet 2 (CI 60730), Yellow 5 (CI 19140), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Fresh Picked Cherries Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "07581724-97ba-4288-bf88-f466590b8a27", "id": "3c4d72bb-a6f6-473a-ab55-0c8e2144cf23", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20121227", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Glycerin, Tetrasodium EDTA, Benzophenone-4, Triethanolamine, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Ext. Violet 2 (CI 60730), Blue 1 (CI 42090), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Cucumber Melon Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "086df8a8-16e7-4932-817f-2c205b4de46b", "id": "7d4562c5-8d03-4e24-a496-88741f946e25", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20131029", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Talc, PEG-8 Distearate, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Hydrated Silica, Maltodextrin, Gelatin Crosspolymer, Hydrolyzed Corn Starch, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Adrenaline Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL PEG-8 DISTEARATE TALC STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz DegreeExtremePDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "08cd4c79-119d-4317-8f40-7c8eb94f582e", "id": "ce9657ac-3ab4-42bc-a7a7-4d105b134523", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20120912", "inactive_ingredient": [ "INACTIVE INGREDIENTS Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax" ], "purpose": [ "PURPOSES Pain reliever/Fever reducer Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "warnings": [ "WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days 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 ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "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? Call 1-800-406-7984" ], "spl_product_data_elements": [ "Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride IBUPROFEN IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GUAR GUM TRISTEARIN HYDROXYPROPYL CELLULOSE FERROSOFERRIC OXIDE KAOLIN POLYETHYLENE GLYCOLS POWDERED CELLULOSE POVIDONE STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE WHITE WAX 423 Caplets" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland you are taking a diuretic" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not 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 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 symptoms continue or get worse any new symptoms appear you get nervous, dizzy, or sleepless fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days redness or swelling is present in the painful area" ], "spl_unclassified_section": [ "OTHER INFORMATION store at 20 - 25 ○ C (68 - 77 ○ F). Avoid excessive heat above 40 ○ C (104 ○ F). read all warnings and directions before use. Keep carton. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age right before or after heart surgery" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL QC QUALITY CHOICE ® NDC 63868-453-20 * Compare to the active ingredients in Advil ® Cold & Sinus NON-DROWSY IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP Cold & Sinus Formula Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID) ٭ Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant FOR RELIEF OF: Sinus Pressure Nasal Congestion Fever 20 COATED CAPLETS † ( † Oval-Shaped Tablets) ٭ nonsteroidal anti-inflammatory drug © DISTRIBUTED BY QUALITY CHOICE 5089124/R0811 This is the 20 count blister carton label for Quality Choice Ibuprofen and Pseudoephedrine HCl Tablets, USP." ], "indications_and_usage": [ "USES Temporarily relieves these symptoms associated with the common cold or flu: fever sinus pressure nasal congestion headache minor body aches and pains" ], "set_id": "093e6388-54f2-4d04-ba55-8f7c9c182a0e", "id": "9b971e5f-98b5-4030-96d0-2b8aa5c03609", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug taking any other product that contains pseudoephedrine or any other nasal decongestant taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin" ], "active_ingredient": [ "ACTIVE INGREDIENTS (IN EACH CAPLET) Ibuprofen, USP 200 mg (NSAID) * Pseudoephedrine HCl, USP 30 mg * nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20120306", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Butyrospermum Parkii (Shea) Butter, Panthenol, Glycerin, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Xanthan Gum, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN if irritation and redness develop." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR KEEP OUT OF REACH OF CHILDREN if irritation and redness develop." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Mint Chocolate Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR" ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "0a306587-5433-41e2-acad-505a56503833", "id": "f5d47be8-e3ff-4a21-a124-4bd98b1a8f3a", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130422", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Coconut Pineapple Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "0a36e65d-5f15-4151-bb98-6f6539c09040", "id": "79419d55-0a44-4a2d-a1d6-8176c13bcee5", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20110406", "inactive_ingredient": [ "Inactive ingredient: soybean oil, wheat germ oil, gamma orizanol, yellow wax, sucrose esters of fatty acids, colostrum basic protein, seaweed clacium powder, red ginseng extract powder, CoQ10, pomegranate concentrated powder, sophorae fructus extract, gelatin, D-sorbitol, gardenia red, cochineal dye mixture, titanium dioxide" ], "keep_out_of_reach_of_children": [ "Keep outof reach of children" ], "purpose": [ "helps enhancing the bone health" ], "warnings": [ "■ Bioisoflavone ① Only use for postmenopausal women ② Do not take in case of pregnancy or lactation ③Keep out of reach of children ④ Do not take if allergic to soy ⑤ Persons with estrogen-dependent cancers should not take product ■ N- acetylglucosamine : Do not take if allergic to crab" ], "spl_product_data_elements": [ "Cheon Shim Bo Yun N-ACETYLGLUCOSAMINE N-ACETYLGLUCOSAMINE N-ACETYLGLUCOSAMINE .ALPHA.-TOCOPHEROL ACETATE, D- .ALPHA.-TOCOPHEROL ACETATE, D- SOY ISOFLAVONES SOY ISOFLAVONES SOYBEAN OIL WHEAT GERM OIL YELLOW WAX CALCIUM ASIAN GINSENG POMEGRANATE SOPHORA FLAVESCENS ROOT GELATIN GLYCERIN SORBITOL TITANIUM DIOXIDE GARDENIA JASMINOIDES FRUIT COCHINEAL pink none 3;hp;x" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "1 day 4 tablets, 1 time 2 tablets" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "only use for postmenopausal women" ], "set_id": "0ab551a2-f744-4278-92b4-97c5cb6fa504", "id": "82c2d9cd-e7ab-4603-959e-c3435b479210", "active_ingredient": [ "Active ingredient: Isoflavone, N-acetylglucosamine, D-alpha tocopherol" ] }, { "effective_time": "20120731", "inactive_ingredient": [ "I n active ingredients cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin" ], "purpose": [ "Purpose Oral pain reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics" ], "questions": [ "Questions or comments? call s at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com" ], "spl_product_data_elements": [ "Baby Orajel Nighttime Instant Relief for Teething Pain Long Lasting Extra Strength Benzocaine BENZOCAINE BENZOCAINE CARBOXYMETHYLCELLULOSE SODIUM MINERAL OIL GELATIN PECTIN PETROLATUM POLYETHYLENE GLYCOLS FD&C RED NO. 40 SACCHARIN SODIUM DIHYDRATE Cherry Flavored" ], "ask_doctor": [ "Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away swelling, rash or fever develops" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions wash hands cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Baby Orajel apply to the affected area up to 4 times daily or as directed by a dentist or doctor for infants under 4 months, ask a dentist or doctor Other information do not use if tube tip is cut prior to opening." ], "do_not_use": [ "do not use more that directed for more than 7 days unless directed by a dentist or doctor When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persists, consult your doctor." ], "package_label_principal_display_panel": [ "Principal Display Panel No. 1 TEETHING BRAND used by Pediatricians Baby Orajel Nighttime Instant Relief for Teething Pain cherry flavored gel NEW and IMPROVED FORMULA LONGER LASTING EXTRA STRENGTH for Nighttime NET WT 0.18 OZ (5.1g) GEL ORAL PAIN RELIEVER FOR TEETHING BENZOCAINE 10% Carton image Carton image" ], "indications_and_usage": [ "Use for the temporary relief of sore gums due to teething in infants and children 4 months or age and older" ], "set_id": "0ab985a1-3a4c-4655-b2a8-6ca04cf48f19", "id": "f54dd296-e7e9-487c-aed4-bfd44fff43c9", "active_ingredient": [ "Active Ingredients Benzocaine 10%" ] }, { "effective_time": "20110111", "inactive_ingredient": [ "Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.", "Inactive Ingredients: hypromellose, polyethylene glycol, propylene glycol, corn starch", "Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.", "Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch", "Inactive Ingredient: Purified water" ], "purpose": [ "Uses: To help prevent infection in: minor cuts; scrapes; burns", "Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.", "Uses temporarily relieves minor aches and pains due to: the common cold headache toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever", "Uses Temporarily relieves minor aches and pains associated with: headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever", "Purpose: Pain reliever, fever reducer", "Purpose: Antihistimine", "Use: For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If ingested, contact a Poison Control Center right away.", "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms", "Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.", "Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only.", "Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.", "Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed", "Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed", "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.", "Warnings Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are: taking any drugs for asthma taking sedatives or tranquilizers", "Warning: For external use only." ], "when_using": [ "Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage", "When using this product: take with food or milk if stomach upset occurs", "When using this product: take with food or milk if stomach upset occurs", "Directions do not use more than directed the smallest effective dose should be used drink a full glass of water with each dose do not take longer than 10 days, unless directed by a doctor", "When using this product Drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitaility may occur, especially in children", "Directions: Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use." ], "spl_product_data_elements": [ "ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE GENUINE TRIPLE ANTIBIOTIC BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B WATER INSECT STING RELIEF PAD BENZOCAINE,ALCOHOL BENZOCAINE BENZOCAINE ALCOHOL ALCOHOL WATER IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POWDERED CELLULOSE STARCH, CORN HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN WHITE 44;352 MEDIQUE DIPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 STARCH, CORN PINK WHITE CPC;835 MEDIQUE APAP Extra Strength ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN CROSPOVIDONE HYDROXYPROPYL CELLULOSE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POLYETHYLENE GLYCOL POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN WHITE AZ;235 ASPIRIN ASPIRIN ASPIRIN ASPIRIN HYPROMELLOSES POLYETHYLENE GLYCOL PROPYLENE GLYCOL STARCH, CORN white 44;157;ASPIRIN Antiseptic Towelette BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER" ], "description": [ "Made in CHINA LOT/EXP:", "Distributed by GENUINE FIRST AID 600 Cleveland Str Suite 400, Clearwater, FL 33755", "Distributed by GENUINE FIRST AID 600 Clevelad Str Suite 400, Clearwater, FL 33755", "LOT/EXP: Made in CHINA 20130301" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if: stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic", "Ask a doctor before use if you have liver disease" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions: do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor. Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: do not give to children under 12 years of age.", "Adults and children: (12 years and older) take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: do not give to children under 12 years of age unless directed by a doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.", "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and consult a doctor: if the condition persists or gets worse; a rash or other allergic reaction develops", "Stop use and ask a doctor If: you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear", "Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint; vomit blood; have bloody or black stools; have stomach pain that does not get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear", "Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately." ], "storage_and_handling": [ "Other information: Store at room temperature.", "Flammable - keep away from fire or flame.", "Other information: Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid excessive heat and humidity; tamper evident sealed packets; Do not use any opened or torn packets", "Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967", "Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967" ], "do_not_use": [ "Do not use: in eyes; over large areas of the body; If allergic to any of the ingredients; for more than one week unless directed by a physician.", "Do not use: In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.", "Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.", "Do not use: if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis", "Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor", "Do not use in the eyes or over large areas of the body." ], "package_label_principal_display_panel": [ "Genuine Triple Antibiotic First Aid Ointment To Help Prevent Infection Each Gram Contains: Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units Net Wt. 0.5g ; (1/64 oz) Manufactured in CHINA for GENUINE FIRST AID.", "Insect Sting Relief Pad Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "IBUPROFEN 2 Tablets", "IBUPROFEN 2 Tablets", "ASPIRIN 2 Tablets", "Antiseptic Towelette Genuine First Aid LLC, Clearwater FL 33755 www.GenuineFirstAid.com 1/pouch GENUINE FIRST AID", "AntisepticTowelette", "Insect Sting Relief Pad", "GenuineTripleAntibiotic", "Ibuprofen 200mg", "Aspirin 325 mg", "APAP_PDP", "apap_pdp", "DIPHEN_PDP", "DIPHEN_PANEL", "ONEPERSONKIT_FRONT", "ONEPERSONKIT_BACK" ], "indications_and_usage": [ "Uses for the temporary relief of minor aches and pains associated with headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever", "Uses Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes" ], "set_id": "0adedf0d-6c71-4ed9-963f-1fc41c1ae0f6", "id": "22f141f4-f307-4e18-a8ca-275e075f2547", "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you are: taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug", "Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swellign is present" ], "active_ingredient": [ "Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units", "Active Ingredient: Purpose: Benzocaine, 6% w/v.................. Topical Anesthetic SD alcohol, 60% w/v.................. Antiseptic", "Active ingredient (in each tablet) Purpose Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Aspirin (NSAID * ) 325 mg............................... Pain Reliever / fever reducer *nonsteroidal anti-inflammatory drug", "Active Ingredient (in each tablet) Purpose Acetaminophen 500 mg............................... Pain Reliever / fever reducer", "Active Ingredient (in each tablet) Purpose Diphenhydramine Hydrochloride 25mg............................... Antihistimine", "Active Ingredient: Purpose Benzalkonium Chloride 0.40%.......... First Aid Antiseptic" ] }, { "effective_time": "20150107", "inactive_ingredient": [ "Inactive ingreients FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide" ], "purpose": [ "Purpose Antiflatulent" ], "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 Stop use and ask a doctor if condition persists 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." ], "spl_product_data_elements": [ "Sanafitil Extra Strength Simethicone FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GELATIN GLYCERIN WATER TITANIUM DIOXIDE DIMETHICONE DIMETHICONE GR" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if condition persists" ], "storage_and_handling": [ "Other information store at a controlled room temperature 15-30°C (59-86°F) protect from heat and moisture" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Gas Relief" ], "indications_and_usage": [ "Uses For Relief of: Bloating Pressure Fullness stuffed feeling commonly referred to as gas" ], "set_id": "0c1467f3-dab6-353b-e054-00144ff8d46c", "id": "0c14873c-f8a5-087a-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients (in each softgel) Simethicone 125mg" ] }, { "effective_time": "20130612", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Ext. Violet 2 (CI 60730), Red 33 (CI 17200), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Passionfruit Fig Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "0c1c57d0-8d73-4b2f-ac66-0e66a60a775f", "id": "a0aa91e0-87db-4028-b93c-976251187939", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20150109", "inactive_ingredient": [ "Inactive ingreients FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide" ], "purpose": [ "Purpose Antiflatulent" ], "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 Stop use and ask a doctor if condition persists 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." ], "spl_product_data_elements": [ "Estomaquil Gas Relief Extra Strength Simethicone FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GELATIN GLYCERIN WATER TITANIUM DIOXIDE DIMETHICONE DIMETHICONE GR" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care professional before use." ], "stop_use": [ "Stop use and ask a doctor if condition persists" ], "storage_and_handling": [ "Other information store at a controlled room temperature 15-30°C (59-86°F) protect from heat and moisture" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Gas Relief" ], "indications_and_usage": [ "Uses For Relief of: Bloating Pressure Fullness stuffed feeling commonly referred to as gas" ], "set_id": "0c3cb08c-301e-71f1-e054-00144ff8d46c", "id": "0c3cb08c-301f-71f1-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients (in each softgel) Simethicone 125mg" ] }, { "effective_time": "20130802", "inactive_ingredient": [ "Inactive ingredients FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol." ], "purpose": [ "Purpose Stool Softener 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 • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Stool Softener Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL SCU1 reddish" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose" ], "storage_and_handling": [ "Other information • each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken." ], "package_label_principal_display_panel": [ "Package Label GERICARE NDC 66336-0792-XX NDC 66336-0792-94 Stool Softener compare to active ingredient in colace Docusate Sodium 120 Softgels 100 mg each NDC 66336-0792-XX" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "set_id": "0c83f999-6c57-4bfd-812d-9600baf5eb09", "id": "fb030a15-7594-4ab1-8162-5ca19944229f", "active_ingredient": [ "Active ingredient (in each softgel) Docusate Sodium 100 mg" ] }, { "effective_time": "20131125", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Honey Extract (Mel, Extrait de miel), Retinyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Sugared Vanilla Wish Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "0e5e1dc7-3098-464d-94ee-bfb74cf15fdc", "id": "12ec258b-90b4-433f-a4bb-ca5d9da68b35", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20131010", "inactive_ingredient": [ "INACTIVE INGREDIENTS Gelatin, Myrrhm, Sesame Oil, Water and Zinc Oxide" ], "purpose": [ "PURPOSE Methyl Salucylate External Analgesic L-Methenol External Analgesic" ], "keep_out_of_reach_of_children": [ "Stop use and ask a doctor if Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away." ], "warnings": [ "WARNINGS For External Use Only. Do not use on wounds, on infected or damaged skin." ], "when_using": [ "Stop use and ask a doctor if Avoid contact with eyes or mucous membranes. Do not bandage tightly. When using for pain of arthritis: In conditions affecting children under 12 years of age If red nose is present If pain persists for more than 10 days" ], "spl_product_data_elements": [ "PAIN GOODBYE AQUEOUS PATCH METHYL SALICYLATE METHYL SALICYLATE SALICYLIC ACID 2-(L-MENTHOXY)ETHANOL 2-(L-MENTHOXY)ETHANOL GELATIN MYRRH SESAME OIL WATER ZINC OXIDE" ], "ask_doctor": [ "WARNINGS For children under 12 years of age, do not use, consult a doctor." ], "openfda": {}, "version": "2986", "dosage_and_administration": [ "Directions Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily. Bandage will remain effective after 24 hours and will be even more effective when using after a bath. Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal. Other Information: Keep container tightly closed. Once opened, fold the opening and keep pressed. Close with a clip. Store at room temperature." ], "stop_use": [ "Stop use and ask a doctor if Condition worsens. Symptom clears up and occurs again within a few days. Symptom persists for more than 7 days. Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs. Excessive irritation of the skin develops." ], "package_label_principal_display_panel": [ "carton.jpg" ], "indications_and_usage": [ "USES Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains." ], "set_id": "0e8b325d-4b41-4f9f-a778-b9b5d1c8525f", "id": "8c3ae600-4511-4868-a9bd-848f707e7f87", "active_ingredient": [ "ACTIVE INGREDIENTS Methyl Salicylate 50 mg L-Methenol 80 mg" ] }, { "effective_time": "20091120", "inactive_ingredient": [ "Inactive ingredients D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol" ], "purpose": [ "Purpose Stool softener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. 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." ], "questions": [ "Questions? 1-888-726-7535 (8am-5pm, EST, Mon.-Fri.)." ], "spl_product_data_elements": [ "DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE POLYETHYLENE GLYCOL 400 GLYCERIN GELATIN SORBITOL WATER PROPYLENE GLYCOL D&C RED NO. 33 DO4" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-6 capsules daily children 2 to under 12 years of age take 1-3 capsules daily children under 2 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "Drug Facts", "" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "do_not_use": [ "Do not use if you are presently taking mineral oil, unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Docusate Sodium capsules USP 50mg Each Softgel Contains: (Docusate Sodium USP 50mg) LOT NO : DRUM NO : MFG DATE : QUANTITY : NDC NO : 68210-0402- EXP DATE : WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C. ACT AND REGULATIONS THEREUNDER. MANUFACTURED BY: SOFTGEL HEALTHCARE PVT LIMITED INDIA LABELLER CODE : 35916 LIC NO. : TN/DRUGS/00002124 MANUFACTURED FOR: SPIRIT PHARMACEUTICALS LLC 225 LINCOLN HWY, STE 205 FAIRLESS HILLS, PA 19030 PH.# 215 943 4000 FAX.# 215 943 4039 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" 1 – 10 2 – 30 3 – 100 4 – 1000 5 – 16000 Principal Display Panel" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "set_id": "0ecd8576-5bc4-45ca-86d8-e6b73ef5aace", "id": "5a59a01e-65e5-484d-8d4e-a25bef6dc4ab", "active_ingredient": [ "Active ingredient (in each capsule) Docusate sodium 50 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1-6 capsules daily
children 2 to under 12 years of age take 1-3 capsules daily
children under 2 years ask a doctor
" ] }, { "effective_time": "20150611", "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Extra Strength Aspirin Free Pain Relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL STEARIC ACID TITANIUM DIOXIDE red, gray and blue L;5" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease." ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "package_label_principal_display_panel": [ "Primary Display Panel Extra Strength Aspirin Free Pain Relief NDC 21130-519-15 Compare to Extra Strength Tylenol® Rapid Release Gels active ingredient* Acetaminophen , 500 mg Pain Reliever Fever Reducer Rapid Release Gelcap 50 GELCAPS SAFEWAY® TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Extra Strength Tylenol® Rapid Release Gels. 50844 REV0513E51915 DISTRIBUTED BY SAFEWAY INC. P.O. BOX 99, PLEASANTON, CA 94566-0009 QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK 1-888-SAFEWAY / www.safeway.com Safeway 44-519 Safeway 44-519" ], "indications_and_usage": [ "Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever" ], "set_id": "0ed80d65-aeab-4f88-86c2-22c266de028b", "id": "c04f7994-d05f-4223-9183-0ada0a897cd1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredient (in each gelcap) Acetaminophen 500 mg" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Glycerin, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Blue 1 (CI 42090), Red 33 (CI 17200), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR avoid contact with eyes. If contact occurs, rinse thoroughly with water. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Black Raspberry Vanilla Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "0f5913d8-58a4-46b1-96b2-f670400fadbf", "id": "abf0439a-9574-456b-991c-b85050d3f4e3", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Cyclopentasiloxane Stearyl alcohol PPG-14 Butyl Ether Fragrance Hydrogenated Castor Oil Talc PEG-8 distearate Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Hydrated Silica Maltodextrin Gelatin Crosspolymer Hydrolyzed Corn Starch BHT Silica Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL PEG-8 DISTEARATE TALC STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz Degree V12 PDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "0fb4abaa-7fe9-4128-a97e-8e9da3c3be73", "id": "4c380459-df30-4038-8762-36878db8e90e", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.0%)" ] }, { "effective_time": "20150128", "inactive_ingredient": [ "Inactive ingredients gelatin,glycerin, PEG 400, propylene glycol, sorbitol Soft gels are imprinted with edible dye-free ink. ©2014, Purdue Products L.P. Dist. by: Purdue Products L.P. Stamford, CT 06901-3431 Made in the USA 303458-0A" ], "purpose": [ "Purpose Stool softener" ], "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": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "questions": [ "Other information each soft gel contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed." ], "spl_product_data_elements": [ "Colace Clear Docusate sodium DOCUSATE SODIUM DOCUSATE GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL Clear to light brown CLR;50" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: _ Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-6 soft gels daily children 2 to under 12 years of age take 1-3 soft gels daily children under 2 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 or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week" ], "how_supplied": [ "" ], "do_not_use": [ "Do not use if you are presently taking mineral oil, unless told to do so by a doctor" ], "package_label_principal_display_panel": [ "Colace Clear ™ 50 mg Carton NDC: 67818-100-28 Colace Clear 50mg" ], "indications_and_usage": [ "" ], "set_id": "0fbb189e-62f3-d9bb-cd48-d88e0648eb50", "id": "50170f82-8611-4f12-b602-b227e8f7b380", "active_ingredient": [ "Drug Facts Colace Clear 50 mg Active ingredient (in each soft gel) Docusate sodium 50 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1-6 soft gels daily
children 2 to under 12 years of age take 1-3 soft gels daily
children under 2 years ask a doctor
" ] }, { "effective_time": "20130612", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Peach Poppy Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "10187bee-182f-428d-bd57-dc14f9f922a7", "id": "fa3a36b8-0a6a-4cb0-b706-6283d60e1cc7", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130612", "inactive_ingredient": [ "Inactive ingredients D&C Yellow #10, edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to make a child sleep with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease glaucoma trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? call 1-877-753-3935 Monday- Friday 9AM- 5PM EST" ], "spl_product_data_elements": [ "Nitetime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P30;94A;35A" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 6 hours swallow whole; do not crush, chew or dissolve children under 12 years: do not use when using other Daytime or Nitetime products, carefully read each label to insure correct dosing" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at room temperature 15°-30°C (59°-86°F) avoid excessive heat" ], "do_not_use": [ "Do not use to make a child sleep with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredients in Vicks® Nyquil® Liquicaps®* *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Liquicaps® Multi symptom Nitetime Liquid Caps cold/flu relief Pain reliever- fever reducer [Acetaminophen] Cough suppressant [Dextromethorphan HBr] Antihistmine [Doxylamine succinate] TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS OPEN OR TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION", "Product Label Nitetime Liquid Caps CareOne" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation" ], "set_id": "101b8b04-37ed-4743-9c25-5d31101280d2", "id": "88d60a0a-91af-4dcd-9e49-57a3f9092a26", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ] }, { "effective_time": "20110322", "inactive_ingredient": [ "Inactive ingredients cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin" ], "purpose": [ "Purpose Oral Pain Reliever" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Allergy Alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics" ], "questions": [ "Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com" ], "spl_product_data_elements": [ "Baby Orajel Instant Relief for Teething Pain Longer Lasting Benzocaine BENZOCAINE BENZOCAINE CARBOXYMETHYLCELLULOSE SODIUM GELATIN MINERAL OIL PECTIN PETROLATUM POLYETHYLENE GLYCOL FD&C RED NO. 40 SACCHARIN SODIUM cherry flavored" ], "ask_doctor": [ "When using this produ c t fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your doctor. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, irritation, pain or redness does not go away, swelling, rash or fever develops" ], "other_safety_information": [ "Other information do not use if tube tip is cut prior to opening" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions wash hands cut open tip of tube on score mark use your fingertip or cotton applicator to apply a small pea-size amount of Baby Orajel apply to the affected area up to 4 times daily or as directed by a dentist or doctor for infants under 4 months of age, ask a dentist or doctor" ], "do_not_use": [ "Do not use more than directed for more than 7 days unless directed by a dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel No 1 TEETHING BRAND used by Pediatricians Baby Orajel Instant Relief for Teething Pain cherry flavored gel NEW AND IMPROVED FORMULA LONGER LASTING NET WT 0.33 OZ (9.4g) Gel ORAL PAIN RELIEVER FOR TEETHING ENZOCAINE 7.5% Carton image Carton image" ], "indications_and_usage": [ "USE For the temporary relief of sore gums due to teething in infants and children 4 months of age and older" ], "set_id": "1051cca1-ff94-4d1a-a5d3-ab943a1321ef", "id": "e59620e3-9ffc-4611-b4d2-1ca88375a427", "active_ingredient": [ "Active ingredients Benzocaine 7.5%" ] }, { "effective_time": "20120123", "purpose": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product, do not use more than directed." ], "questions": [ "Questions? 1-800-251-3374" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever" ], "set_id": "10ae1774-6e64-4b75-941b-8facd63a66e8", "id": "a22863d6-9aef-4758-83cd-beafe91f3bb3", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
" ], "inactive_ingredient": [ "Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks DayQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine FD&C YELLOW NO. 6 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOLS POVIDONE PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE DQUIL" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil or NyQuil® products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Manufactured by Procter & Gamble Cincinnati OH 45202 Distributed by Convenience Valet ® Melrose Park, IL 60160" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 2 Capsule Pouch Package CONVENIENCE CV VALET ® COLD RELIEF VICKS ® DayQuil ® 2 LiquiCaps ® PRINCIPAL DISPLAY PANEL - 2 Capsule Pouch Package" ], "purpose_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20150331", "inactive_ingredient": [ "Inactive Ingredients Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water." ], "purpose": [ "Purpose Nighttime sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings Do not use in children under 12 years of age. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments Call 1-855-314-1850" ], "spl_product_data_elements": [ "Nightime Sleep Aid Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 1000 SORBITOL POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL TITANIUM DIOXIDE 206" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor. children under 12 years: do not use" ], "spl_unclassified_section": [ "Other Information save carton for full directions and warnings" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG NDC:58805-006-00 Softgel Liquid filled 8a592765-figure-01 8a592765-figure-02" ], "indications_and_usage": [ "Uses For relief of occasional sleeplessness." ], "set_id": "114b71f9-36b1-4372-805e-65cbb61f2925", "id": "8a592765-a0be-417d-9ca5-ba530235a986", "active_ingredient": [ "Active Ingredient (in each softgel) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special" ], "purpose": [ "Purpose Stool softener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use - if you are currently taking mineral oil, unless directed by a doctor Ask a doctor before use if you have stomach pain, nausea or vomiting have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use you need to use a stool softener 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." ], "questions": [ "Questions? Adverse drug event call (800) 687-0176" ], "spl_product_data_elements": [ "Docusate Sodium Docusate Sodium D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOLS PROPYLENE GLYCOL DOCUSATE SODIUM DOCUSATE SORBITOL 51A Two toned- white and clear red" ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain, nausea or vomiting have noticed a sudden change in bowel habits that lasts over 2 weeks" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions doses may be taken as a single daily dose or in divided doses adults and children 12 years and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 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 you need to use a stool softener laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information each capsule contains sodium 6 mg store at room temperature 15 o -30 o C (59 o -86 o F) Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing" ], "do_not_use": [ "Do not use - if you are currently taking mineral oil, unless directed by a doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Blenheim Pharmacal, Inc. NDC 10544-130-20 Docusate Sodium [Stool Softener] Softgel Capsules, 100mg 20 Softgel Capsules 100mg 20ct" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "set_id": "117c82a6-2063-566b-e054-00144ff88e88", "id": "117c74e5-7084-543d-e054-00144ff88e88", "active_ingredient": [ "Active ingredient (in each softgel) Docusate sodium 100 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor
" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, 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:" ], "when_using": [ "When using this product Avoid alcoholic drinks. Marked drowsiness may occur. Excitability may occur, especially in children. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery." ], "spl_product_data_elements": [ "Diphenhydramine HCL Diphenhydramine HCL FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PH014" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture" ], "do_not_use": [ "Do not use With any other product containing Diphenhydramine HCL, including one applied topically." ], "package_label_principal_display_panel": [ "Principal Display Panel Blenheim Pharmacal, Inc. NDC 10544-166-15 Diphenhydramine HCl Capsules, USP 25mg 15 Capsules 25mg 15ct" ], "indications_and_usage": [ "Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes." ], "set_id": "117fead9-699d-57ae-e054-00144ff88e88", "id": "11a88159-9fdc-1983-e054-00144ff8d46c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use If you have: Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Glaucoma If you are taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine" ], "dosage_and_administration_table": [ "
Adults and children 12 years or over 1 to 2 capsule
Children 6 to under 12 years 1 capsule
Children under 6 years ask a doctor
" ] }, { "effective_time": "20150317", "inactive_ingredient": [ "Inactive ingredients FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol." ], "purpose": [ "Purpose Stool Softener 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 • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Stool Softener Docusate Sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL DOCUSATE SODIUM DOCUSATE SCU1 reddish" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose" ], "storage_and_handling": [ "Other information • each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken." ], "package_label_principal_display_panel": [ "Principal Display Panel Docusate Sodium [Stool Softener] Softgels, USP 100mg 20 Softgels NDC 10544-168-20 100mg 20ct" ], "indications_and_usage": [ "Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours" ], "set_id": "118054c8-1a22-324b-e054-00144ff8d46c", "id": "117ffce1-c52d-3684-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient (in each softgel) Docusate Sodium 100 mg" ] }, { "effective_time": "20120613", "inactive_ingredient": [ "Other ingredients: Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polacrylamide, C13-14 Isoparaffin, Laureth-7, Triticum Vulgare (wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein, Saccharide Isomerate, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Propylene Glycol, Camellia Sinensis Leaf Extract, Panthenol, Ubiquinone, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Chlorella Vulgaris Extract, Phytosterol Isostearate, Allantoin, Ascorbyl Methylsilanol Pectinate, Tocopheryl Acetate, Lecithin, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Trisodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben." ], "purpose": [ "Purpose: Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "warnings": [ "Cautions: For external use only. Avoid contact with eyes." ], "spl_product_data_elements": [ "Time Dynamics Time Protector Daily Defense SPF 15 Octinoxate, Zinc Oxide OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE WATER GELATIN VITAMIN A PALMITATE TRIDECYL NEOPENTANOATE DIMETHICONE GLYCERYL MONOSTEARATE GLYCERIN POLYACRYLAMIDE (1500 MW) C13-14 ISOPARAFFIN LAURETH-7 WHEAT GERM SACCHARIDE ISOMERATE SOYBEAN CERAMIDE 3 PROPYLENE GLYCOL GREEN TEA LEAF PANTHENOL UBIDECARENONE CHONDRUS CRISPUS CHLORELLA VULGARIS ALLANTOIN ASCORBYL METHYLSILANOL PECTINATE .ALPHA.-TOCOPHEROL ACETATE EGG PHOSPHOLIPIDS MEDIUM-CHAIN TRIGLYCERIDES DIISOPROPYL ADIPATE EDETATE TRISODIUM DIAZOLIDINYL UREA METHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "To use: In the morning after cleansing. Smooth over face and throat. Clinically, allergy, irritancy tested." ], "package_label_principal_display_panel": [ "Jafra Time Dynamics Time protector Daily Defense Cream SPF 15 Crema Facial Hidratante De Dia Con *FPS 15 with/con intellishield 50 ml 1.7 Fl Oz image of carton art" ], "indications_and_usage": [ "Discontinue use if signs of irritation occur." ], "set_id": "11a9f402-2a83-4ff9-bd02-3c5a7ff34bf9", "id": "bf3b0d26-ca18-4563-821b-86c469f5c24b", "active_ingredient": [ "Sunscreen Active Ingredients (SPF 15): Octinoxate/Ethylhexyl Methoxycinnamate, Zinc Oxide Purpose: Sunscreen Keep out of reach of children Discontinue use if signs of irritation occur. Cautions: For external use only. Avoid contact with eyes. To use: In the morning after cleansing. Smooth over face and throat. Clinically, allergy, irritancy tested. Other ingredients: Water/Aqua, Gelatin, Retinyl Palmitate, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Glyceryl Stearate, Glycerin, Polacrylamide, C13-14 Isoparaffin, Laureth-7, Triticum Vulgare (wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein, Saccharide Isomerate, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Propylene Glycol, Camellia Sinensis Leaf Extract, Panthenol, Ubiquinone, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4, Chlorella Vulgaris Extract, Phytosterol Isostearate, Allantoin, Ascorbyl Methylsilanol Pectinate, Tocopheryl Acetate, Lecithin, Caprylic/Capric Triglyceride, Diisopropyl Adipate, Trisodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben." ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Glycerin, Acacia Senegal Gum, Gelatin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Triethanolamine, Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Yellow 10 (CI 47005), Blue 1 (CI 42090), Red 40 (CI 16035)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Rainkissed Leaves Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "11c832bc-0f3f-456f-8569-2e06e9e8e4e8", "id": "19fc4543-188e-4361-acdc-4b24a4cb9c1a", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20121231", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis leaf juice, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminate metasilicate, methyl paraben, peg-40 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate" ], "purpose": [ "Uses Temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin, broken or irritated skin" ], "spl_product_data_elements": [ "DG HEALTH EXTRA STRENGTH MEDICATED MENTHOL MENTHOL MENTHOL ALUMINUM HYDROXIDE EDETATE DISODIUM GELATIN KAOLIN METHYLPARABEN GLYCERIN TITANIUM DIOXIDE ISOPROPYL MYRISTATE WATER" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "DISTRIBUTED BY DOLGEN CORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 MADE IN KOREA" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if conditions worsens redness is present irritation develops avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin, broken or irritated skin" ], "storage_and_handling": [ "Other information store at room temperature, not to exceed 86°F (30°C)" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Directions adults and children over 12 years remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area apply one patch to affected area repeat as necessary, but no more than 3 times daily children under 12 years of age: ask a doctor" ], "set_id": "132fddd1-d9ab-4097-9e1e-9a8ba3cb4e60", "id": "784b4164-3b17-4e56-bb4e-e872c5fde188", "active_ingredient": [ "Active ingredient Purpose Menthol 5%...................................................................Topical analgesic" ] }, { "effective_time": "20130331", "inactive_ingredient": [ "Inactive ingredients aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monostearate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water" ], "purpose": [ "Uses Temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains muscle sprains bruises cramps" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin" ], "spl_product_data_elements": [ "ASSURED PAIN RELIEF HOT PATCH MENTHOL, CAPSICUM OLEORESIN MENTHOL MENTHOL CAPSAICIN CAPSAICIN ALOE VERA LEAF ALUMINUM HYDROXIDE EDETATE DISODIUM GELATIN KAOLIN METHYLPARABEN POLYSORBATE 80 SORBITOL TARTARIC ACID TITANIUM DIOXIDE WATER" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Distributed by: Greenbrier International, Inc. 500 Volvo Parkway Chesapeake, VA 23320 Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms persist more than 7 days or clear up and occur again within a few days redness is present skin irritation develops" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Directions Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 12 years of age: do not use, consult a doctor For easy application: partially peel back protective film and apply exposed patch to site of pain Carefully remove remaining film while pressing patch to skin for secure adhesion Store unused patch in pouch. Reseal pouch after opening" ], "set_id": "13b9440e-2ee3-45c6-ab71-fdabb25ae115", "id": "bdfcac69-a9c7-485f-8d70-c765bb8fc1bb", "active_ingredient": [ "Active ingredients Purpose Menthol 30mg...............................................................................Topical Analgesic Capsicum Extract (capsaicin) 8.3mg...............................................Topical Analgesic" ] }, { "effective_time": "20151116", "inactive_ingredient": [ "Inactive ingredients edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol" ], "purpose": [ "Purpose Pain reliever Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage." ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Sinus Relief Daytime Acetaminophen, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 GELATIN GLYCERIN PROPYLENE GLYCOL POVIDONES SORBITOL POLYETHYLENE GLYCOLS 48A" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions take only as directed (see overdosse warning) do not exceed 4 doses per 24 hours adults and children 12 years and over: 2 liquid caps with water every 4 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 redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number for better identification, keep liquid caps in carton until used" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal display panel NDC 21130-355-08 SAFEWAY® care Quality Guaranteed Non-Drowsy Daytime Sinus Relief Acetaminophen 325 mg - Pain Reliever Phenylephrine HCl 5 mg - Nasal Decongestant Compare to Vicks ® DayQuil ® Sinex ® Daytime Sinus Relief LiquiCaps ® active ingredients* • Sinus headache & pain • Sinus pressure & congestion • Pseudoephedrine free Actual Size 24 LIQUID CAPS * This product is not manufactured or distributed by Procter & Gamble, distributors of Vicks ® DayQuil ® Sinex ® Daytime Sinus Relief LiquiCaps ® . 50844 REV1012C55308 DISTRIBUTED BY SAFEWAY INC. P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-SAFEWAY / www.safeway.com Product of Canada OUR PROMISE QUALITY & SATISFACTION 100% GUARANTEED OR YOUR MONEY BACK TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Safeway 44-553 Safeway 44-553" ], "indications_and_usage": [ "Uses temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion" ], "set_id": "14930698-0b37-4375-ae61-31650fab7768", "id": "cf216669-224a-4177-8a06-e075e742c0ad", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "active_ingredient": [ "Active ingredients (in each liquid cap) Acetaminophen 325 mg Phenyelphrine HCl 5 mg" ] }, { "effective_time": "20130422", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Honey Extract (Mel, Extrait de miel), Retinyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Yellow 6 (CI 15985), Red 33 (CI 17200), Red 40 (CI 16035), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand reamy Pumpkin Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "149636d2-69b0-4d60-8c6e-245ba0db7b73", "id": "9652cba4-db1a-42b6-bec9-d4dd013cedc4", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130212", "purpose": [ "Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-570-8650" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding , ask a health professional before use." ], "storage_and_handling": [ "Other information avoid excessive heat and humidity store between 15-30°C (59-86°F) do not use if pouch is torn or open see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains itching of the nose or throat itchy, watery eyes helps decongest sinus openings and passages" ], "set_id": "14d1f439-16a3-4fd8-949b-5b29d5b25d42", "id": "2eee76ce-e881-4ca7-b7d5-2dbf60dbff77", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine HCl 5 mg Nasal decongestant" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, sodium lauryl sulphate, edetaet disodium, dioctyl sodium sulphosuccinate, polyvinylpyrollidone, gelatin, corn starch, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium benzoate, sodium starch glycolate, stearic acid, purified talc, titanium dioxide, yelllow iron oxide." ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "ConRx Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Chlorpheniramine maleate Chlorpheniramine Phenylephrine Hydrochloride Phenylephrine SILICON DIOXIDE SODIUM LAURYL SULFATE EDETATE DISODIUM DOCUSATE SODIUM POVIDONE K90 GELATIN STARCH, CORN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 6000 SODIUM BENZOATE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW CRX" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions • do not take more than directed ( see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours, do not take more than 8 tablets in 24 hours, children under 12 years, consult a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 2 Caplets × 50 Pouch Box See New Warnings Information & Directions Compare to the Active Ingredients in Tylenol ® Allergy* Multi-Symptom ConRx™ Allergy Sinus Sneezing - Runny Nose - Congestion Acetaminophen Headache Phenylephrine HCl Sinus Pressure/Nasal Congestion Chlorpheniramine Maleate Watery Eyes/Runny Nose TO OPEN PUSH IN TAB AND PULL OUT Compare to the Active Ingredients in Tylenol ® Allergy* Multi-Symptom 50 Pouches of 2 Caplets Each Principal Display Panel - 2 Caplets × 50 Pouch Box" ], "purpose_table": [ "
Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever
Chlorpheniramine maleate 2 mg Antihistamine
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20130423", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Gelatin, Glycerin, Xanthan Gum, Acacia Senegal Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Benzophenone-4, Tetrasodium EDTA, Triethanolamine, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Fresh Picked Apple Blossoms Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "14edf59b-4a79-4fa7-a6f7-40bd65c6a762", "id": "a0b320b4-dae0-46ae-bab4-e3030b06b2ab", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20110509", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Yellow 6 (CI 15985), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Fresh Picked Pear Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "15333412-46c2-4cb3-8415-4ce1f2ccf7f2", "id": "3c3e520f-92fd-48de-b108-ba1055141754", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20120306", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Panthenol, Retinyl Palmitate, Acacia Senegal Gum, Gelatin, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Disodium Laureth Sulfosuccinate, Polyethylene, Triethanolamine, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Blue 1 (CI 42090), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Tropical Berries Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "15c00e38-095e-4ddb-8fc0-1bdfb92ae34c", "id": "e81777a7-3ccf-4f2c-a0bf-c69e8fea857f", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130630", "inactive_ingredient": [ "Inactive ingredients: Aloe Vera, Aluminum Hydroxide, Disodium Edate, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Polysorbate 80, Tocopherol Acetate, Magnesium Aluminometasilicate, Castor Oil, Tartaric Acid, Polyethylene Glycol Monostearate, BHT, Sodium POlyacrylate. Release liner: Polypropylene, Non-woven material: Polyester non-woven fabric" ], "purpose": [ "Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains muscle sprains bruises cramps" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For External Use Only" ], "when_using": [ "When using this product: use only as directed do not bandage tightly or use with heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin" ], "spl_product_data_elements": [ "Goodsense Extra Strength Cold and Hot Medicated Menthol MENTHOL MENTHOL ALOE VERA LEAF ALUMINUM HYDROXIDE GELATIN KAOLIN METHYLPARABEN GLYCERIN TITANIUM DIOXIDE ISOPROPYL MYRISTATE WATER POLYVINYL ALCOHOL POLYSORBATE 80 ALPHA-TOCOPHEROL ACETATE CASTOR OIL TARTARIC ACID BUTYLATED HYDROXYTOLUENE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Distributed by: Geiss, Destin and Dunn, Inc. Peachtree City, GA 30269 Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if: condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days" ], "storage_and_handling": [ "Other information Store at room temperature, not to exceed 86°F (30°C) Reports of serious side effects associated with the use of this product can be sent to: 17211 Valley View Ave. Cerritos, CA 90703" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Directions adults and children over 12 years: carefully remove backing from patch apply sticky side of patch to affected area should be used up to 8 hours should be used no more than 3 times a day children 12 years or younger: ask a doctor" ], "set_id": "15fe419e-2f51-438d-b6c9-630dc9ededd7", "id": "ecfe8535-bb84-4407-bfb6-fccf7325b649", "active_ingredient": [ "Active ingredient Purpose Menthol 5%..........................................................Topical analgesic" ] }, { "effective_time": "20131015", "inactive_ingredient": [ "Inactive ingredients edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan *may contain this ingredient" ], "purpose": [ "Purpose Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 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 avoid alcoholic drinks." ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "NightTime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL P50;A99;S90" ], "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" ], "other_safety_information": [ "Other information store at 15°-30°C (59°-86°F)" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by 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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness." ], "do_not_use": [ "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal Display Panel ** Compare to the active ingredient in Unisom® SleepGels® Maximum Strength NightTime Sleep-Aid DIPHENHYDRAMINE HCl, 50 mg • LIQUID FILLED CAPSULES • SAFE, NON-HABIT FORMING Softgels ONE SOFTGEL PER DOSE **This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®. DISTRIBUTED BY ONPOINT, INC. 2 PARAGON DRIVE MONTVALE, NJ 07645 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.", "Package Label Live Better Maximum Strength NightTime Sleep Aid Softgel Diphenhydramine HCl 50 mg" ], "indications_and_usage": [ "Use for relief of occasional sleeplessness." ], "set_id": "16dc2588-c125-4e11-8077-2b42cd88424e", "id": "7c8a719a-2182-425f-8211-a7f91eb7b923", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each softgel) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20100901", "purpose": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product, do not use more than directed." ], "questions": [ "Questions? 1-800-251-3374" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever" ], "set_id": "17aebf77-55d8-4a02-8391-28bbd9c3b373", "id": "896b3914-8b53-4fcd-94d9-e84daf967cfe", "active_ingredient": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 LiquiCaps with water every 4 hours
children under 12 years ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide" ], "warnings": [ "Warnings Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with other medicines containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 600 GELATIN POVIDONE SORBITOL WATER BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take only as recommended - see Overdose warning do not exceed 6 doses per 24 hours adults and children 12 years and over 2 LiquiCaps with water every 4 hours children under 12 years ask a doctor when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with other medicines containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules Each Softgel Contains: (Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Phenylephrine Hydrochloride USP 5mg) LOT NO: DRUM NO: MFG DATE: QUANTITY: NDC NO: 68210-0101- EXP DATE: WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. MANUFACTURED BY: SOFTGEL HEALTHCARE PVT LIMITED INDIA LABELLER CODE: 35916 LIC NO.: TN/DRUGS/00002124 MANUFACTURED FOR: SPIRIT PHARMACEUTICALS LLC 225 LINCOLN HWY, STE 205 FAIRLESS HILLS, PA 19030 PH.# 215 943 4000 FAX.# 215 943 4039 CAUTION: \"FOR MANUFACTURING, PROCESSING OR REPACKING\" 1 – 4 2 – 100 3 – 1000 4 – 5000 5 – 10000 6 - 2500 PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "overdosage": [ "Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ] }, { "effective_time": "20100618", "purpose": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product, do not use more than directed." ], "questions": [ "Questions? 1-800-251-3374 www.vicks.com" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at room temperature" ], "indications_and_usage": [ "Uses temporarily relieves sinus symptoms: sinus pain headache nasal and sinus congestion" ], "set_id": "184203e9-6c40-4e69-b08a-c8117e3b2391", "id": "28ac4450-1447-4690-9110-82217ddca819", "active_ingredient": [ "Active ingredients (in each LiquiCap) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over 2 LiquiCaps with water every 4 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland When using this product, do not use more than directed. Stop use and ask a doctor if redness or swelling is present you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur symptoms do not get better within 7 days or are accompanied by a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Vicks DayQuil Sinus Acetaminophen and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Phenylephrine Hydrochloride Phenylephrine" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions take only as recommended - see Overdose warning do not exceed 6 doses per 24 hours adults and children 12 years and over 2 LiquiCaps with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202." ], "stop_use": [ "Stop use and ask a doctor if redness or swelling is present you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur symptoms do not get better within 7 days or are accompanied by a fever" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "active_ingredient_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 12 LiquiCaps Carton VICKS ® NON-DROWSY DayQuil ® SINUS Relief of Your Daytime Sinus Symptoms Acetaminophen...Sinus Headache and Pain Phenylephrine...Sinus Pressure and Congestion 12 LiquiCaps ® Alcohol Free/Antihistamine Free See Drug Facts Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each LiquiCap) Purpose
Acetaminophen 325 mg Pain reliever
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20131030", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "1.6 oz PDP DegreeMSSexyIntriguePDP", "2.6 ox PDPb DegreeMSSexyIntriguePDPb" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "187be720-2b90-4300-878c-9f9d86d1b525", "id": "af84c5a7-e40c-4e89-8a20-d7e2e7037251", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] }, { "effective_time": "20130724", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand New England Autumn Bouquet Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "189ff4de-05eb-4678-8474-4c762f3e8fa6", "id": "cdeff614-f8cc-4af1-91aa-0abd8421355c", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130820", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035), Yellow 6 (CI 15985)" ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Vanilla Buttercream Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "1908fd07-4e04-434f-bb41-373bd9fbfbe1", "id": "29bbdf6a-b1d9-412e-a1e2-1c063f53791b", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Fragrance (Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acacia Senegal Gum, Gelatin, Polyethylene, Disodium Laureth Sulfosuccinate, Glycerin, Triethanolamine, Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Ext. Violet 2 (CI 60730), Red 33 (CI 17200), Blue 1 (CI 42090), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Moonligh Path Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "1916cc1a-165e-4581-bba6-1e970533fd95", "id": "80644b9f-acf6-47e1-ac99-868fb3e79f57", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130215", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Xanthan Gum, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Triethanolamine, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Mango Paradise Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "194d5f85-fd29-45bc-92fb-836dfad018d0", "id": "f8f6e4ed-2665-4a5f-9cfb-bcf54c48d24b", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20101229", "inactive_ingredient": [ "Other Ingredients Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcelluslose, Dicalcium Phosphate, dI-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflaving. Contains Soy. May contain Povidone and Polydextrose. Contains No artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk based by-products." ], "contraindications": [ "CONTRAINDICATIONS Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a poison control center immediately." ], "precautions": [ "PRECAUTIONS Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "warnings": [ "WARNINGS Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins." ], "spl_product_data_elements": [ "Multi-Nate 30 beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION CAPRYLIC/CAPRIC MONO/DIGLYCERIDES CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE MALTODEXTRIN STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE ACACIA SODIUM ALGINATE POLYETHYLENE GLYCOL SUCROSE STARCH, CORN HYDROGENATED SOYBEAN OIL HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE ALPHA-TOCOPHEROL, DL- TITANIUM DIOXIDE TRIACETIN POLYSORBATE 20 RIBOFLAVIN RE;316" ], "openfda": {}, "version": "11", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION Before, during and after pregnancy, take one tablet by mouth daily, or as directed by a physician." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088." ], "how_supplied": [ "HOW SUPPLIED Multi-Nate 30 is available as a dark pink tablet imprinted “RE 316”: bottles of 100 tablets NDC 68032-444-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store a controlled room temperature 15-30C (59-86F). Keep in a cool, dry place. WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only" ], "package_label_principal_display_panel": [ "PACKAGING label" ], "indications_and_usage": [ "INDICATIONS AND USAGE Multi-Nate 30 is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception. Multi-Nate 30: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid." ], "set_id": "195435f6-3c9b-4ac5-9502-859ef03c7523", "id": "7164daaf-b77f-4bff-bb44-8b7623cf52c2" }, { "effective_time": "20121206", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Triethanolamine, Polyethylene, Gelatin, Glycerin, Xanthan Gum, Acacia Senegal Gum, Benzophenone-4, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 10 (CI 47005), Yellow 5 (CI 19140), Blue 1 (CI 42090), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Citrus Crush Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "1959b3c8-9187-4adc-84e7-ea667fe503b7", "id": "1ece08b0-5b01-4fee-b311-f1821f697550", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "spl_product_data_elements": [ "DayTime Nitetime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl Nitetime Acetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P30;94A;35A Daytime acetaminophen, dextromethorphan HBr, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BUTYLATED HYDROXYANISOLE BUTYLATED HYDROXYTOLUENE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITAN SORBITOL P19;95A;36A" ], "active_ingredient": [ "Active ingredients for Daytime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg", "Active ingredients for Nitetime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ], "purpose": [ "Purpose for Daytime Pain reliever/fever reducer Cough suppressant Nasal decongestant", "Purpose for Nighttime Pain reliever/fever reducer Cough suppressant Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nitetime only)" ], "warnings": [ "Warnings Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to make a child sleep (Nitetime only) with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis glaucoma (Nitetime only) diabetes (Daytime only) heart disease (Daytime only) thyroid disease (Daytime only) high blood pressure (Daytime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nitetime only) When using this product, do not use more than directed. In addition, when using Nitetime: excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (Daytime only) pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use to make a child sleep (Nitetime only) with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis glaucoma (Nitetime only) diabetes (Daytime only) heart disease (Daytime only) thyroid disease (Daytime only) high blood pressure (Daytime only)" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nitetime only)" ], "when_using": [ "When using this product, do not use more than directed. In addition, when using Nitetime: excitability may occur, especially in children avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (Daytime only) pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve Daytime : adults and children 12 years and over: take 2 softgels with water every 4 hours Nitetime : adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use" ], "storage_and_handling": [ "Other information store at room temperature 15°-30°C (59°-86°F) avoid excessive heat" ], "inactive_ingredient": [ "Inactive ingredients Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol *may contain this ingredient Nitetime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan sorbitol" ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®† NON-DROWSY DAYTIME / MULTI-SYMPTOM NITETIME COLD/FLU RELIEF LIQUID CAPS Acetaminophen - Pain Reliever-Fever Reducer / Acetaminophen - Pain Reliever-Fever Reducer Dextromethorphan HBr - Cough Suppressant / Dextromethorphan HBr - Cough Suppressant Phenylephrine HCl - Nasal Decongestant / Doxylamine Succinate - Antihistamine DAYTIME SOFTGELS / NITETIME SOFTGELS Alcohol Free Antihistamine Free When using Daytime and Nitetime products, carefully read the labeling to insure correct dosing KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. DISTRIBUTED BY FOODHOLD U.S.A., LLC LANDOVER, MD 20785 †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.", "Product Label Care One Daytime / Nitetime Cold Flu Relief Acetaminophen 325 mg, Dextromethorphan HBr 10 mg; Phenylephrine HCl 5 mg; Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine succinate 6.25 mg" ], "set_id": "196d8d95-a2db-4695-b3b5-daced8417f5b", "id": "985662a0-7a67-4031-8538-3f7d9d4f4dae", "effective_time": "20130620", "version": "4", "openfda": {} }, { "effective_time": "20141216", "inactive_ingredient": [ "Inactive ingredients ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide" ], "purpose": [ "Purpose Pain reliever Nighttime sleep-aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery" ], "questions": [ "Questions or comments? 1-877-932-7948" ], "spl_product_data_elements": [ "Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C RED NO. 3 HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES POLYETHYLENE GLYCOLS PROPYLENE GLYCOL STEARIC ACID TITANIUM DIOXIDE with gray band" ], "ask_doctor": [ "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "8", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number avoid high humidity" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age" ], "package_label_principal_display_panel": [ "Principal Display Panel EQUAL INE ® compare to Extra Strength Tylenol ® PM active ingredients* NDC 41163-556-09 extra strength acetaminophen PM gelcaps acetaminophen 500mg diphenhydramine HCl 25mg • pain reliever/nighttime sleep aid • non-habit forming • rapid release 20 gelcaps actual size DOES NOT CONTAIN GLUTEN *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol ® PM. 50844 REV0413D55609 DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Equaline 44-556 Equaline 44-556" ], "indications_and_usage": [ "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "set_id": "19cbd789-5370-49a6-b728-8eba48e8d35a", "id": "40f75bc1-a966-4102-b835-e413b07f2665", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each gelcap) Acetaminophen 500 mg Diphenhydramine HCl 25 mg" ] }, { "effective_time": "20110708", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Glycerin, Xanthan Gum, Acacia Senegal Gum, Gelatin, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Yellow 5 (CI 19140), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT STOP USE AND ASK A DOCTOR avoid contact with eyes. If contact occurs, rinse thoroughly with water. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT" ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Oatmeal Raisin Cookie Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "1a129cc7-a114-4ef5-aa35-27f36ef338e7", "id": "7f356b90-32ce-4902-99d9-93c7019c2bf8", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20151110", "inactive_ingredient": [ "Inactive Ingredients FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide" ], "purpose": [ "Purpose Cough Suppressant Expectorant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm(mucus) cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments Toll free 1-855-314-1850" ], "spl_product_data_elements": [ "Cough and Congestion DM Dextromethorphan and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN GELATIN GLYCERIN POLYETHYLENE GLYCOL 1000 POVIDONE POVIDONE K30 PROPYLENE GLYCOL FD&C RED NO. 40 SORBITOL TITANIUM DIOXIDE Light 601" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Do not take more than 12 capsules in any 24 hour period This adult product is not intend for use in children under 12 years of age Age dose Adults and children 12 years and over 2 capsules every 4 hours Children under 12 years Do not use" ], "spl_unclassified_section": [ "Other Information store at 20-25 °C(68-77 °F) avoid excessive heat above 40 °C (104°F)" ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cough and Congestion DM, NDC:58805-007-75 25*300 Softgel Liquid filled 4e88b254-figure-01" ], "indications_and_usage": [ "Uses Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes" ], "set_id": "1a7fa7fd-435f-4a94-9d7e-7b7e83e9f97e", "id": "4e88b254-c0b1-48bf-9ca5-b13a22118204", "active_ingredient": [ "Active Ingredient (in each liquid filled capsule) Dextromethorphan Hydrobromide, USP 10mg Guaifenesin, USP 200mg" ], "dosage_and_administration_table": [ "
Age dose
Adults and children 12 years and over 2 capsules every 4 hours
Children under 12 years Do not use
" ] }, { "effective_time": "20130111", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Butyrospermum Parkii (Shea) Butter, Tetrasodium EDTA, Benzophenone-4, Panthenol, Ultramarines (CI 77007), Acacia Senegal Gum, Gelatin, Glycerin, Red 40 (CI 16035), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Tocopheryl Acetate, Retinyl Palmitate, Honey Extract (Mel, Extrait de miel), Methylisothiazolinone, Red 4 (CI 14700), Xanthan Gum, Red 33 (CI 17200), Yellow 5 (CI 19140), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Tropical Sorbet Float Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "1ad9c853-9466-4479-b40e-625cc7b7022f", "id": "98298170-6b69-4c59-a496-c9a8c0fa433d", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20150727", "inactive_ingredient": [ "Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sorbitol" ], "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 (1-800-222-1222) right away." ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 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 excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "when_using": [ "When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children" ], "questions": [ "Questions or comments? 1-800-426-9391" ], "spl_product_data_elements": [ "Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN WATER SORBITOL A;33" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions take oevre 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 softgetls children 6 to under 12 years of age 1 softgel 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." ], "storage_and_handling": [ "Other information store at 25ºC (77ºF); excursions permited between 15º-30ºC (59º-86ºF) protect from heat, humidity and light see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin" ], "package_label_principal_display_panel": [ "Principal display panel RITE AID® PHARMACY *Compare to the active ingredient in Benadryl® Dye-Free Allergy LIQUI-GELS® allergy relief diphenhydramine HCl 25 mg antihistamine DYE FREE relief of: sneezing itchy, watery eyes runny nose itchy throat 24 SOFTGELS *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Dye-Free Allergy LIQUI-GELS®. 50844 ORG041229908 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Rite Aid 44-299 Rite Aid 44-299" ], "indications_and_usage": [ "Uses temporarily relieves these sy mptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing" ], "set_id": "1b314d4d-2987-401e-a705-ccfa586b07a8", "id": "b11219a4-324f-466a-b8a6-211071ae1a5e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredient (in each soft gel) Diphenhydramine HCl 25 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over 1 to 2 softgetls
children 6 to under 12 years of age 1 softgel
children under 6 years of age do not use this product in children under 6 years of age
" ] }, { "effective_time": "20100830", "inactive_ingredient": [ "INACTIVE INGREDIENTS benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, 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. (1-800-222-1222" ], "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. 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. Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative. When using this product you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine. If pregnant or breast-feeding, 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 you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine." ], "questions": [ "QUESTIONS OR COMMENTS? Distributed by: Qualitest Pharmaceuticals, Inc. 130 Vintage Drive Huntsville, AL 35811 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE" ], "ask_doctor": [ "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." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "OTHER INFORMATION Store at controlled room temperature 59-86 degrees F." ], "package_label_principal_display_panel": [ "Package Label 25 mg Capsules 25 mg Capsules" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose." ], "set_id": "1b53ec3a-dec0-48c2-831d-72b3d88242f1", "id": "1b53ec3a-dec0-48c2-831d-72b3d88242f1", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPSULE) Diphenhydramine Hydrochloride 25 mg" ] }, { "effective_time": "20120810", "inactive_ingredient": [ "Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "purpose": [ "Uses To decrease bacteria on the skin. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact aPoisonControlCenter immediately. Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours. Warnings For external use only. FLAMMABLE. Keep away from heat and flame. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact aPoisonControlCenter immediately. Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours. Warnings For external use only. FLAMMABLE. Keep away from heat and flame. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "warnings": [ "Warnings For external use only. FLAMMABLE. Keep away from heat and flame. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "spl_product_data_elements": [ "Bodycology Enchanted Forest Kit Enchanted Forest Bodycology Enchanted Forest Ethyl ALcohol ALCOHOL ALCOHOL water Propylene Glycol TROLAMINE GELATIN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ULTRAMARINE BLUE FD&C RED NO. 4 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 D&C RED NO. 33 Nourishing Body Bodycology WATER SOYBEAN OIL STEARIC ACID ISOPROPYL PALMITATE GLYCERYL STEARATE SE GLYCERYL MONOSTEARATE COCOA BUTTER ALOE VERA LEAF SHEA BUTTER .ALPHA.-TOCOPHEROL ACETATE SODIUM ASCORBYL PHOSPHATE CETYL ALCOHOL TROLAMINE DIMETHICONE EDETATE DISODIUM SULISOBENZONE BUTYLATED HYDROXYTOLUENE PHENOXYETHANOL METHYLISOTHIAZOLINONE FD&C RED NO. 4 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "package_label_principal_display_panel": [ "Bodycology Moisturizing Hand Sanitizer with Aloe Vera kills 99% of germs without water Enchanted Forest 30 mL 1 Fl Oz image of bottle art image of bodycream art" ], "indications_and_usage": [ "Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours. Warnings For external use only. FLAMMABLE. Keep away from heat and flame. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "set_id": "1b808143-2455-4a2b-b84c-51fdf4ffd618", "id": "506a9281-832b-4ff0-8d65-351b4ac68a31", "active_ingredient": [ "Active ingredient Purpose Ethyl Alcohol 75% Antiseptic image of backer Uses To decrease bacteria on the skin. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact aPoisonControlCenter immediately. Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours. Warnings For external use only. FLAMMABLE. Keep away from heat and flame. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions -Wet hands with product. -Briskly rub hands together until dry. -For children under 6, use only under adult supervision. -Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, TocopherylAcetate, AloeBarbadensisLeaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ] }, { "effective_time": "20130617", "inactive_ingredient": [ "Inactive Ingredients benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel 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 with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get very drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc." ], "spl_product_data_elements": [ "Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE AP;021" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts .", "Other Information store at 15-30 °C (59-86 °F) protect from moisture For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-0241-2 Packaged by: A-S Medication Solutions Libertyville, IL 60048 0241-2.jpg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes" ], "set_id": "1bb6d0da-16b2-4abc-a83b-7f41dd4e46b9", "id": "710f7015-3dac-4926-b9ce-c1fa96dbafc5", "active_ingredient": [ "Active Ingredient (in each capsule) Diphenhydramine HCl 50 mg" ] }, { "effective_time": "20130521", "inactive_ingredient": [ "Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "purpose": [ "Uses To decrease bacteria on the skin. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Discontinue use if irritation and redness develop . If condition persists for more than 72 hours, consult a doctor. Warnings For external use only. FLAMMABLE. Keep away from flame or high heat. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Discontinue use if irritation and redness develop . If condition persists for more than 72 hours, consult a doctor. Warnings For external use only. FLAMMABLE. Keep away from flame or high heat. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "warnings": [ "Warnings For external use only. FLAMMABLE. Keep away from flame or high heat. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "spl_product_data_elements": [ "Exotic Cherry Hand Sanitizer bodycology Alcohol ALCOHOL ALCOHOL WATER CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) TROLAMINE PROPYLENE GLYCOL GELATIN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ULTRAMARINE BLUE FD&C RED NO. 4 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 D&C RED NO. 33" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "package_label_principal_display_panel": [ "Bodycology hand sanitizer 1 Fl Oz./ 30 mL backer bottle" ], "indications_and_usage": [ "Discontinue use if irritation and redness develop . If condition persists for more than 72 hours, consult a doctor. Warnings For external use only. FLAMMABLE. Keep away from flame or high heat. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ], "set_id": "1c0fea1b-dbd0-42b3-92b5-7cac6488290a", "id": "48389dcb-b4eb-4e1e-9fc8-e5837ea4d587", "active_ingredient": [ "Active ingredient Purpose Alcohol 75% Antiseptic Uses To decrease bacteria on the skin. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Discontinue use if irritation and redness develop . If condition persists for more than 72 hours, consult a doctor. Warnings For external use only. FLAMMABLE. Keep away from flame or high heat. When using this product Avoid contact with eyes. If contact occurs, flush eyes with water. Avoid contact with broken skin. Directions Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants. Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007). May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200)." ] }, { "effective_time": "20121227", "inactive_ingredient": [ "Inactive Ingredients D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water." ], "purpose": [ "Purpose Stool softener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings - Do not use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present for longer than one 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 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." ], "spl_product_data_elements": [ "STOOL SOFTENER DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SORBITOL D&C RED NO. 33 TITANIUM DIOXIDE FD&C BLUE NO. 1 WATER P10;51A" ], "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": "2", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1- 2 capsules preferably at bedtime children 6 to 12 years of age: take 1 capsule at bedtime" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health care 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" ], "storage_and_handling": [ "Other information each capsule contains: sodium 6 mg store at controlled room temperature 15 o - 30 o C (59 o - 86 o F) do not use if imprinted safety seal under cap is broken or missing. *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace ®" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to active ingredient of COLACE®* stool softener Docusate sodium 100 mg Distributed by: American Sales Company 4201 walden avenue, Lancaster, NY 14086", "Product Label Docusate Sodium 100 mg CareOne" ], "indications_and_usage": [ "Uses for the prevention of dry, hard stools for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours." ], "set_id": "1c5aa329-441c-40de-bda6-8132caf25ae9", "id": "e12462d6-7d6c-4d7a-b057-11129e97f9a5", "active_ingredient": [ "Active Ingredient (in each capsule) Docusate Sodium 100 mg Purpose Stool softener" ] }, { "effective_time": "20120202", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Dimethicone Paraffin Microcrystalline Wax Fragrance (Parfum) Silica Caprylic/Capric Triglyceride Sodium Starch Octenylsuccinate Dimethicone Crosspolymer Hydrated Silica Maltodextrin Gelatin Crosspolymer Hydrolyzed Corn Starch Cellulose Gum BHT" ], "purpose": [ "Purpose anti-perspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE1" ], "spl_product_data_elements": [ "Degree Clinical Protection Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 DIMETHICONE MICROCRYSTALLINE WAX SILICON DIOXIDE HYDRATED SILICA MALTODEXTRIN STARCH, CORN GELATIN CARBOXYMETHYLCELLULOSE SODIUM BUTYLATED HYDROXYTOLUENE PARAFFIN" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions ▪ apply to underarms only ▪ before bed, apply two clicks of product to each underarm" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.7 oz Degree Clinical Motion Sexy Intrigue PDP", "PDP 2.7 oz carton Degree Clinical Motion Sexy Intrigue Carton" ], "indications_and_usage": [ "Uses ▪ reduces underarm wetness ▪ 24 hour protection ▪ extra effective" ], "set_id": "1c5bc184-966f-432b-8f08-ca6efb0890c2", "id": "04784ca5-cd6e-42bd-b187-6b5447e27f31", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (20%)" ] }, { "effective_time": "20150121", "inactive_ingredient": [ "Inactive Ingredients FD&C Green #3, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Blue #1, D&C Yellow Yellow #10, titanium dioxide." ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "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 (1-800-222-1222). Taking more than the recommended dose can cause serious health problems. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland When using this product do not exceed recommended dosage excitability may occur, especially in childrenmarked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use" ], "when_using": [ "When using this product do not exceed recommended dosage excitability may occur, especially in childrenmarked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "questions": [ "Questions or comments Call toll free 1-877-99-GENOM (43666)" ], "spl_product_data_elements": [ "Next Night Time Cold and Flu Relief Acetaminophen, Dextromethorphan, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE FD&C GREEN NO. 3 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONES PROPYLENE GLYCOL WATER SORBITOL FD&C BLUE NO. 1 D&C YELLOW NO. 10 TITANIUM DIOXIDE" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland" ], "other_safety_information": [ "Other information store at room temperature do not use if blister is torn or open" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ■ take only as recommended (see Warnings) ■ do not exceed 4 doses per 24 hours Adults and children 12 years and over: ■ take 2 softgels with water every 6 hours Children 4 to under 12 years: ■ Ask a doctor Children under 4 years: ■ Do not use" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product to make a child sleep" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Z:\\SPL-OTC Mono\\Genomma\\Next Night Time\\LB1357_Next Night Time.jpg" ], "indications_and_usage": [ "Uses temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever, runny nose and sneezing" ], "set_id": "1c791a43-03db-402b-a9db-b4b4f4b764af", "id": "574f4302-2db9-48b8-94f6-c0671fa38846", "active_ingredient": [ "Active ingredient Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg" ] }, { "effective_time": "20150807", "drug_interactions": [ "Drug unteraction precautions do not use if you are taking a prescription monoamine oxidase ihibitor (MAOI) (certain drug for depression, psychoatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presctiption drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "inactive_ingredient": [ "DC red No. 33, FDC Blue No.1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water." ], "purpose": [ "PURPOSE Analgesic Decongestant Antihistamine Antitussive" ], "keep_out_of_reach_of_children": [ "KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, get medical help or contac a poison control center immediately. Prompt medical attention is critical for adults as well as children ever if you do not notice any sings or symptoms ." ], "warnings": [ "WARNINGS DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen." ], "when_using": [ "When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitabiloty may occur, especially in children if nervousness, dizziness or spleeplessness occur discontinue use and consult a doctor" ], "spl_product_data_elements": [ "XL3 XTRA acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN D&C RED NO. 33 FD&C BLUE NO. 1 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GELATIN GLYCERIN POLYETHYLENE GLYCOL 600 POLYETHYLENE GLYCOL 1000 POVIDONE PROPYLENE GLYCOL WATER ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE SOFT LIQUID FILLED CAPSULE Xtra" ], "warnings_and_cautions": [ "Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relivers fever reducers. Acetaminophen may casuse liver damage Ask a doctor befor use you have Glaucoma, breathing problems such as emphysema or chronic bronchitis, heart disease, diabetes, thyroid disease. difficulty in urination due to enlagement of the prostate gland Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucis) unless directed by doctor" ], "ask_doctor": [ "If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor if you are pregnant or breast feeding, ask a health professional before use" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults and children 12 years of age and older; take 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by doctor. For children under 12 years of age consult a doctor" ], "stop_use": [ "Stop taking this product and ask a doctor if yoi have pain, fever or sympoms that persist or get worse , new symptoms occur redness or swelling these may be be signs of a serious condition" ], "user_safety_warnings": [ "USES Temporaruly relieves the symptoms due to common cold and allergies: Cough, nasal congestion, runny nose, sneezing, watery eyes, fever, aches and pains. WARNINGS DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen." ], "package_label_principal_display_panel": [ "XL3 XTRA" ], "indications_and_usage": [ "Adults and children 12 years of age and older; take 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by doctor. For children under 12 years of age consult a doctor" ], "set_id": "1cbb8491-6ef7-45af-e054-00144ff88e88", "id": "1cbb8491-6ef8-45af-e054-00144ff88e88", "active_ingredient": [ "DRUG FACTS Active Ingredient in each capsule Acetaminophen 250mg Phenylepherine Hydrochloride 5mg Chlorpheniramide Maleate 2mg Dextromethorphan Hydrobromide 10mg" ] }, { "effective_time": "20100730", "inactive_ingredient": [ "INACTIVE INGREDIENTS Lactose, starch, gelatin with bisulfites and artificial colors." ], "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. (1-800-222-1222" ], "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. 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. Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative. When using this product you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine. If pregnant or breast-feeding, 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 you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine." ], "questions": [ "QUESTIONS OR COMMENTS? Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A. call toll free 734-743-6000 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW" ], "spl_product_data_elements": [ "DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE" ], "ask_doctor": [ "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." ], "openfda": {}, "version": "1", "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use." ], "spl_unclassified_section": [ "DRUG FACTS", "DIRECTIONS Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor", "OTHER INFORMATION Store at controlled room temperature 59-86 degrees F." ], "package_label_principal_display_panel": [ "Package Label 25 mg Capsules 25 mg Capsules", "Package Label 50 mg Capsules 50 mg Capsules" ], "indications_and_usage": [ "USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose." ], "set_id": "1d026ead-c3de-4dc6-9d3c-5a603f6dde4e", "id": "1d026ead-c3de-4dc6-9d3c-5a603f6dde4e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking taking tranquilizers or sedative." ], "active_ingredient": [ "ACTIVE INGREDIENT (IN EACH CAPSULE) Diphenhydramine Hydrochloride 25 mg & 50 mg" ] }, { "effective_time": "20130422", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Butyrospermum Parkii (Shea) Butter, Panthenol, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Glycerin, Xanthan Gum, Gelatin, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 33 (CI 17200), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Caramel Apple Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "1d7da798-a1d1-4740-a3c1-ae0718588b62", "id": "1996a4a3-ff54-447f-9a84-ddb89996f12d", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20120621", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane Stearyl Alcohol C12-15 Alkyl Benzoate PPG-14 Butyl Ether Hydrogenated Castor Oil Fragrance (Parfum) Dimethicone Polyethylene Helianthus Annuus (Sunflower) Seed Oil Sodium Starch Octenylsuccinate Caprylic/Capric Triglyceride Maltodextrin Hydrolyzed Corn Starch Gelatin Cellulose Gum Silica BHT" ], "purpose": [ "Purpose anti-perspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-DEGREE" ], "spl_product_data_elements": [ "Degree Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum cation CYCLOMETHICONE 5 DIMETHICONE STEARYL ALCOHOL C12-15 ALKYL BENZOATE PPG-14 BUTYL ETHER HYDROGENATED CASTOR OIL SUNFLOWER OIL MALTODEXTRIN STARCH, CORN GELATIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM BUTYLATED HYDROXYTOLUENE" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions ▪ apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "PDP 2.6 oz Degree Fresh Energy 2.6 oz", "48 Hour Label 48 hour label" ], "indications_and_usage": [ "Uses ▪ reduces underarm wetness" ], "set_id": "1e167278-86fa-4fa7-a1aa-665b4b11db2e", "id": "b4a58efd-b7e8-4059-aaef-0ccf7d8559e3", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (18.2%)" ] }, { "effective_time": "20110330", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Magnesium stearate, Vitamin A palmitate, Thiamine mononitrate, Vitamin B3, Niacin (from Inositol hexanicotinate), Folic acid, Vitamin B12, Magnesium citrate, Magnesium oxide, Zinc gluconate, Zinc oxide, Selenium, Copper gluconate, Manganese, Chromium, L-arginine HCL, N-acetyl-L-cysteine, Ipriflavone, Ginkgo, Grape (seed), Ginger (root), Alpha lipoic acid, Garlic (bulb), PABA (Para-aminobenzoic acid), Black cohosh, Vinpocetine, Black pepper (fruit), Cownzyme Q10, Gelatin, Rice flour." ], "purpose": [ "PURPOSE: Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear." ], "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: Use only as directed. If you are presently taking blood thinning agents or any medications or 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? Call 877-212-7282 Dist By: Vita Sciences Princeton Sciences Almont, NY 10952 USA" ], "spl_product_data_elements": [ "Tinnitus DX Calcarea carbonica, Carbo vegetabilis, Chininum sulphuricum, Cimicifuga racemosa, Cinchona officinalis, Coffea cruda, Graphites, Kali carbonicum, MAGNESIUM STEARATE OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE ACTIVATED CHARCOAL ACTIVATED CHARCOAL QUININE SULFATE QUININE BLACK COHOSH BLACK COHOSH CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK ARABICA COFFEE BEAN ARABICA COFFEE BEAN GRAPHITE GRAPHITE POTASSIUM CARBONATE POTASSIUM CATION LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SODIUM SALICYLATE SODIUM CATION SALICYLIC ACID SALICYLIC ACID VITAMIN A PALMITATE THIAMINE MONONITRATE NIACIN INOSITOL NIACINATE FOLIC ACID METHYLCOBALAMIN MAGNESIUM CITRATE MAGNESIUM OXIDE ZINC GLUCONATE ZINC OXIDE SELENIUM COPPER GLUCONATE MANGANESE ACETYLCYSTEINE IPRIFLAVONE GINKGO GINGER ALPHA LIPOIC ACID GARLIC AMINOBENZOIC ACID BLACK COHOSH VINPOCETINE BLACK PEPPER UBIDECARENONE GELATIN RICE CHROMIUM VITIS VINIFERA SEED natural gelatin none none" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS: For the first 30-90 days, take 2 capsules twice daily with food and 8 oz water. Thereafter, reduce dosage to 1 capsule twice daily. For best results use daily for 3-5 months. For ongoing exposure to loud noise, take preventative dosage of 1 capsule twice daily." ], "information_for_patients": [ "OTHER INFORMATION: Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing. Each capsule contains Magnesium 60mg Each capsule contains Niacin 25mg Niacin may cause a harmless flush reaction in a small percentage of people. In the event of flushing, redness, itching or dizziness, drink 10 oz of water and take an antihistamine. The sensation should diminish within 10-20 minutes. For those sensitive to niacin, reduce dosage to one capsule 2 x per day for 2-3 weeks until tolerance is increased. To further prevent flushing, avoid warm/hot beverages and food for 90 minutes before and after dose. One may take low dose aspirin 30 minutes prior as additional prevention." ], "package_label_principal_display_panel": [ "Tinnitus DX Homeopathic Remedy Relief from: Ringing or buzzing in ears Ear noise Sensitivity to sound Doctor Recommended 60 Capsules Tinnitus DX" ], "indications_and_usage": [ "PURPOSE: Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear." ], "set_id": "1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f", "id": "a2b4738b-db33-4f58-80b6-e5fc163f3043", "active_ingredient": [ "ACTIVE INGREDIENTS: Calcarea carbonica 8X, 30X, Carbo vegetabilis 8X, 12X, 30X, Chininum sulphuricum 12X, 30X, Cimicifuga racemosa 3X, 6X, 12X, 30X, Cinchona officinalis 3X, 6X, 30X, Coffea cruda 3X, 12X, Graphites 8X, 12X, 30X, Kali carbonicum 12X, 30X, Lycopodium clavatum 6X, 12X, 30X, Natrum salicylicum 6X, Salicylicum acidum 6X." ] }, { "effective_time": "20151015", "inactive_ingredient": [ "Inactive ingredients ammonium hydroxide, black iron oxide, croscarmellose sodium, crospovidone, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, red iron oxide, shellac glaze, silica gel, simethicone, stearic acid, titanium dioxide, yellow iron oxide" ], "purpose": [ "Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "warnings": [ "Warnings This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 gelcaps in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "when_using": [ "When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-800-774-2678" ], "spl_product_data_elements": [ "Multi-Symptom Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE CROSCARMELLOSE SODIUM D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE gray band 44;591" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease diabetes heart disease high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition" ], "storage_and_handling": [ "Other information store at controlled room temperature 15º-30º C (59º-86ºF) see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "package_label_principal_display_panel": [ "Principal Display Panel The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. CVS® pharmacy Compare to the active ingredients in Tylenol® Cold Multi-Symptom Nighttime Caplets* SEE NEW WARNINGS INFORMATION Multi-Symptom COLD RELIEF PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT, COUGH SUPPRESSANT, ANTIHISTAMINE NIGHTTIME TO LET YOU SLEEP CONTAINS 4 MEDICINES Headache/Fever Sore Throat - Acetaminophen Nasal Congestion - Phenylephrine HCl Coughing - Dextromethorphan HBr Runny Nose - Chlorpheniramine RAPID RELEASE Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2001 CVS/pharmacy www.cvs.com 1-200-shop-CVS 50844 ORG081059103 TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING Princple Display" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache nasal congestion cough sore throat sinus congestion and pressure sneezing and runny rose helps clear nasal passages relieves cough to help you sleep temporarily reduces fever" ], "set_id": "1e86fa7e-a04d-491c-b4a4-0b3954941294", "id": "f8c9db7b-a137-4b6f-a2b8-9df5b9f72f9e", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg" ] }, { "effective_time": "20130521", "inactive_ingredient": [ "INACTIVE INGREDIENTS Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol." ], "purpose": [ "PURPOSE Cough Suppressant" ], "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 USEYou are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product." ], "spl_product_data_elements": [ "Adult Long Lasting-Cough Relief Dextromethorphan HBr,USP DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GELATIN SORBITAN SORBITOL FD&C BLUE NO. 1 WATER POLYETHYLENE GLYCOL 400 POVIDONE K30 GLYCERIN FD&C RED NO. 40 PROPYLENE GLYCOL 26" ], "ask_doctor": [ "ASK A DOCTOR BEFORE USE IF a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS do not take more than 8 liquidgels in any 24-hour period adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed children under 12 years : ask a doctor" ], "pregnancy_or_breast_feeding": [ "PREGNANCY/BREASTFEEDING Ask a health professional before use." ], "stop_use": [ "STOP USE AND ASK DOCTOR IF Cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition." ], "storage_and_handling": [ "STORAGE TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING store at 20º-25ºC (68º-77ºF) avoid excessive heat above 40ºC (104ºF) protect from light use by expiration date on package" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL CARTON LABEL PDP NDC # 68016-026-20 Adult Long-Lasting Cough Relief DEXTROMETHORPHAN HBr, USP 15mg COUGH SUPPRESSANT Relieves cough for upto 8 hours Non-drowsy Non-Narcotic formula 20 softgels BOTTLE LABEL PDP NDC # 68016-026-20 Adult Long-Lasting Cough Relief DEXTROMETHORPHAN HBr, USP 15mg COUGH SUPPRESSANT Relieves cough for about 8 hours Non-Drowsy Non-Narcotic Formula 20 Softgels Dex-cdc-ct-20sfg Dex-cdc-bt-20sfg" ], "indications_and_usage": [ "USE(S) Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold." ], "set_id": "1e92cbc2-8ec7-442e-a6ec-d069080c53fd", "id": "1e92cbc2-8ec7-442e-a6ec-d069080c53fd", "active_ingredient": [ "ACTIVE INGREDIENT(S) Dextromethorphan HBr, USP 15 mg" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Glycerin, Triethanolamine, Acacia Senegal Gum, Gelatin, Polyethylene, Disodium Laureth Sulfosuccinate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Red 33 (CI 17200), Green 5 (CI 61570), Yellow 5 (CI 19140), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop or increase. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Midnight Pomegranate Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop or increase." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "1f292d2a-dcb2-49b7-b65b-4484f5a86be2", "id": "df1f191d-27e2-4f98-bd8e-a6ff617bf727", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20131015", "inactive_ingredient": [ "Inactive ingredients aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate" ], "purpose": [ "Purpose Topical Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged skin" ], "questions": [ "Questions or comments? 1-800-WALGREENS (1-800-925-4733)" ], "spl_product_data_elements": [ "Cool n Heat Patch for Back Extra Strength Menthol Menthol Menthol Aloe Vera Leaf Aluminum Hydroxide Edetate Disodium Gelatin Kaolin Methylparaben Glycerin Titanium Dioxide Isopropyl Myristate Water PEG-4 Stearate Polyvinyl Alcohol Polysorbate 80 Alpha-Tocopherol Acetate Silodrate Castor Oil Tartaric Acid Butylated Hydroxytoluene" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions adults and children 12 years of age and older peel off protective backing and apply sticky side to affected area carefully remove backing from patch apply one patch to affected area repeat as necessary, but no more than 4 times daily Children under 12 years of age consult a doctor" ], "stop_use": [ "Stop use and ask a doctor if conditions worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present skin irritation develops" ], "storage_and_handling": [ "Other information store at room temperature" ], "package_label_principal_display_panel": [ "Image of box label Image of pouch label" ], "indications_and_usage": [ "Uses Temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains muscle sprains bruises cramps" ], "set_id": "1f86a35b-a7df-4692-8c6b-cca8d7fad83e", "id": "a9a1b401-911e-4504-a898-657326fa2c20", "active_ingredient": [ "Active Ingredient Menthol 5%" ] }, { "effective_time": "20120924", "purpose": [ "Active ingredients (in each gelcap) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions or comments? 1-877-717-2824 or www.benadryl.com" ], "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). Avoid high humidity. tamper evident statement see side panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies: runny nose nasal congestion headache sore throat cough sneezing minor aches and pains itchy, watery eyes itching of the nose or throat sinus congestion and pressure temporarily reduces fever" ], "set_id": "1fb8243d-2249-4898-ab99-1f0dd6f122b0", "id": "0fa83c5d-a031-4be0-8db8-a730256ff562", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each gelcap) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, corn starch, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, edetate calcium disodium, FD&C red #40, FD&C yellow #6, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 gelcaps in 24 hours which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than 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." ], "spl_product_data_elements": [ "Benadryl Allergy Plus Cold Acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride Acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine benzyl alcohol ferrosoferric oxide butylparaben carboxymethylcellulose sodium starch, corn D&C red no. 28 D&C yellow no. 10 aluminum oxide edetate calcium disodium FD&C red no. 40 FD&C yellow no. 6 gelatin hypromelloses magnesium stearate methylparaben cellulose, microcrystalline polyethylene glycols polysorbate 80 propylparaben ferric oxide red sodium citrate sodium lauryl sulfate sodium propionate sodium starch glycolate type a potato titanium dioxide ferric oxide yellow grey subcoat; gelatin dipped Ben;AC" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each gelcap) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "purpose_table": [ "
Active ingredients (in each gelcap) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Diphenhydramine HCl 12.5 mg Antihistamine/cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] }, { "effective_time": "20130925", "inactive_ingredient": [ "Inactive ingredients D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide *may contain this ingredient" ], "purpose": [ "Purpose Antigas" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "questions": [ "Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST" ], "spl_product_data_elements": [ "Gas Relief Extra Strength SIMETHICONE DIMETHICONE DIMETHICONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES PEPPERMINT OIL WATER SORBITAN SORBITOL TITANIUM DIOXIDE PO;S1;SCU" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions adults : swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours unless directed by a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information store at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat, and moisture" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to Gas-X® active ingredient ** Gas Relief Simethicone 125 mg Relief of: bloating/ pressure/ fullness/ gas extra strength gluten free SOFTGELS TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. **This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®. Another Quality Product Distributed by McKesson One post street, San Francisco, CA 94104 Money back guarantee www.healthmart.com/healthmartbrand", "Product Label Simethicone 125 mg softgels Health Mart Pharmacy" ], "indications_and_usage": [ "Uses for the relief of pressure, bloating, and fullness commonly referred to as gas" ], "set_id": "1fe46eda-ea7d-4746-9d9a-f378838509fd", "id": "998bce44-9c35-40af-a2c6-c89626bfe912", "active_ingredient": [ "Active ingredient (in each softgel) Simethicone 125 mg" ] }, { "effective_time": "20130609", "inactive_ingredient": [ "Inactive Ingredients benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel 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 with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get very drowsy avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use." ], "questions": [ "Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc." ], "spl_product_data_elements": [ "Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE BENZYL ALCOHOL BUTYLPARABEN D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM LAURYL SULFATE AP;020" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Drug Facts .", "Other Information store at 15-30 °C (59-86 °F) protect from moisture For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 54569-0239-0 Packaged by: A-S Medication Solutions Libertyville, IL 60048 0239-0.jpg" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose itchy nose or throat sneezing itchy, watery eyes" ], "set_id": "2170657d-5647-4dd3-8197-14e6bab30304", "id": "e9726281-9273-44ab-bcd6-9a828a986c7a", "active_ingredient": [ "Active Ingredient (in each capsule) Diphenhydramine HCl 25 mg" ] }, { "effective_time": "20140916", "purpose": [ "Active ingredients (in each geltab) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery" ], "questions": [ "Questions or comments? call 1-877-895-3665" ], "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). Avoid high humidity. do not use if carton is opened, or neck wrap or foil inner seal imprinted \"SAFETY SEAL®\" is broken or missing see end panel for lot number and expiration date" ], "indications_and_usage": [ "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "set_id": "21e6ce85-91f2-492b-b60b-84de9a38a3a6", "id": "6ccc2cf4-d199-44c9-a52d-d44ce64f3920", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "active_ingredient": [ "Active ingredients (in each geltab) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 2 geltabs at bedtime do not take more than 2 geltabs of this product in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients benzyl alcohol, butylparaben, castor oil, D&C red no. 28, edetate calcium disodium, FD&C blue no. 1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, simethicone, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age 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 disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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." ], "spl_product_data_elements": [ "Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine benzyl alcohol butylparaben castor oil D&C red No. 28 edetate calcium disodium FD&C blue No. 1 gelatin hypromelloses magnesium stearate methylparaben powdered cellulose propylene glycol propylparaben shellac sodium citrate sodium lauryl sulfate sodium propionate sodium starch glycolate type A potato titanium dioxide white and blue geltab printed TYLENOL PM in gray ink TYLENOL;PM" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 geltabs at bedtime do not take more than 2 geltabs of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients" ], "active_ingredient_table": [ "
Active ingredients (in each geltab) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL My-CoachSleep ™ EXCLUSIVE ACCESS FREE WITH PURCHASE NDC 50580-176-10 See New Warnings Information & Directions Extra Strength TYLENOL ® PM Non-habit forming Pain Reliever Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl 100 GELTABS Geltabs* * Gelatin-Coated Tablets PRINCIPAL DISPLAY PANEL" ], "purpose_table": [ "
Active ingredients (in each geltab) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
" ] }, { "effective_time": "20130724", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Georgia Bourbon Peach Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "21ea0732-1481-40df-973e-214967736ceb", "id": "6f10d7ac-dd0b-4b83-8aec-640aa1a20eae", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20130423", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Helianthus Annuus (Sunflower) Seed Oil, Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Tocopheryl Acetate, Retinyl Palmitate, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 40 (CI 16035), Red 33 (CI 17200), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Coral Reef Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "2245cac1-95aa-441c-987a-d6904060ca24", "id": "08059bac-09c0-410a-b8b3-a17ad0325600", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "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": "20130221", "inactive_ingredient": [ "Inactive Ingredient LACTOSE MONOHYDRATE", "Inactive Ingredient STARCH, CORN", "Inactive Ingredient GELATIN", "Inactive Ingredient METHYLPARABEN", "Inactive Ingredient TITANIUM DIOXIDE", "Inactive Ingredient MAGNESIUM STEARATE", "Inactive Ingredient TALC", "Inactive Ingredient SODIUM STARCH GLYCOLATE TYPE A POTATO" ], "purpose": [ "Purpose Antihistamine" ], "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": [ "Warning If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "spl_product_data_elements": [ "APTRIZINE 24-HOUR ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN GELATIN METHYLPARABEN TITANIUM DIOXIDE MAGNESIUM STEARATE TALC SODIUM STARCH GLYCOLATE TYPE A POTATO white no score 10mg" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Dosage and Administration Adults and children 6years andover One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. Adults 65years and over: ask a doctor. Children under 4-6 years of age: ask a doctor Children under 4 years of age: ask a doctor Consumers with liver or kidney disease: ask a doctor" ], "package_label_principal_display_panel": [ "DISPLAY PANEL product" ], "indications_and_usage": [ "Indications and Usage 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": "22e5db90-4cee-47af-9e3e-3636d99974ba", "id": "113f7b27-dc67-473f-80ed-275c08320439", "active_ingredient": [ "active ingredient CETIRIZINE HYDROCHLORIDE" ] }, { "effective_time": "20131122", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Olea Europaea (Olive) Fruit Extract, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Triethanolamine, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Red 33 (CI 17200), Ext. Violet 2 (CI 60730), Yellow 5 (CI 19140)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Twisted Peppermint Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin." ], "set_id": "2386080c-98f1-4b8b-bd17-8ede559a1c46", "id": "e79f873c-a94f-455c-b312-0684b3e70c40", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Glycerin, Triethanolamine, Acacia Senegal Gum, Gelatin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Xanthan Gum, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Blue 1 (CI 42090)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation or redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Cucumber Melon Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation or redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "239201c4-820b-47ed-beb9-134fa20e485d", "id": "00365bf6-a141-40a0-9259-4802928df940", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20100101", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Glycerin, Acacia Senegal Gum, Gelatin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Triethanolamine, Xanthan Gum, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035), Yellow 6 (CI 15985)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Wild Honeysuckle Triclosan TRICLOSAN TRICLOSAN WATER" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING MM1" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "239a579a-df2d-4345-b5df-397b54f48af6", "id": "540d5a3c-fac7-41a0-bfcd-a7a7486b5c31", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20110107", "inactive_ingredient": [ "INACTIVE INGREDIENTS Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Honey Extract (Mel, Extrait de Miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Tetrasodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 40 (CI 16035), Red 33 (CI 17200)." ], "purpose": [ "PURPOSE Antibacterial" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS For external use only. WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR if irritation and redness develop. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "WHEN USING THIS PRODUCT avoid contact with eyes. If contact occurs, rinse thoroughly with water." ], "spl_product_data_elements": [ "Anti-Bacterial Deep Cleansing Hand Lemon Clementine Triclosan TRICLOSAN TRICLOSAN WATER TROLAMINE LAURYL SULFATE PROPYLENE GLYCOL LAURIC DIETHANOLAMIDE HONEY BAMBUSA VULGARIS TOP COCONUT ALOE VERA LEAF BLACK OLIVE SHEA BUTTER PANTHENOL VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL ACETATE, D- TROLAMINE DISODIUM LAURETH SULFOSUCCINATE ACACIA GELATIN GLYCERIN XANTHAN GUM EDETATE SODIUM SULISOBENZONE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 ALCOHOL D&C RED NO. 33" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "DIRECTIONS Wet hands, work into a rich lather Rinse well" ], "stop_use": [ "STOP USE AND ASK A DOCTOR if irritation and redness develop." ], "spl_unclassified_section": [ "COMPANY INFORMATION Bath & Body Works, Distr. Reynoldsburg, Ohio 43068 1-800-395-1001 www.bathandbodyworks.com" ], "package_label_principal_display_panel": [ "PRODUCT PACKAGING Front Label Back Label" ], "indications_and_usage": [ "USE Handwashing to decrease bacteria on skin" ], "set_id": "2457ef1e-90e7-4bfe-9351-b8f90f060100", "id": "f49fbb02-ee64-4be7-9e5c-cf4b691b8461", "active_ingredient": [ "ACTIVE INGREDIENT Triclosan 0.3%" ] }, { "effective_time": "20151125", "inactive_ingredient": [ "Inactive ingredients FD&C Red #40, Gelatin, Glycerin, Polyethylene Glycol 400, Sorbitol Special, FD&C Yellow #6 and Purified Water. Manufactured & Distributed by: Swiss Caps USA, Inc. Miami, FL 33186 Repackaged by: American Health Packaging Columbus, OH 43217" ], "purpose": [ "Purpose Stool Softener" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use If you are currently taking mineral oil, unless directed by a doctor. When abdominal pain, nausea, or vomiting are present. For longer than one 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 or you fail to have a bowel movement after use. If pregnant or breast-feeding, ask a health professional before use." ], "spl_product_data_elements": [ "Docusate Sodium Docusate Sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL FD&C YELLOW NO. 6 WATER DOCUSATE SODIUM DOCUSATE Reddish SCU1" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children over 12 years of age: Take orally 1 to 2 softgels at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children 6-12 years of age: Take orally softgels at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 6 years of age: Do not us this product for children under 6 years of age, unless directed by a doctor." ], "spl_unclassified_section": [ "Other information Each capsule contains 5 mg of Sodium. Store at room temperature 15° - 30°C (59° - 86°F)." ], "package_label_principal_display_panel": [ "Package Label - Principal Display Panel Docusate Sodium, USP 100 mg capsule" ], "indications_and_usage": [ "Uses For relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours. Helps to prevent dry, hard stools." ], "set_id": "24ae1e96-3061-447f-8497-2a18741744ac", "id": "255db7fa-e30a-2cae-e054-00144ff8d46c", "active_ingredient": [ "Active ingredient (in each capsule) Docusate Sodium, USP 100mg" ] }, { "effective_time": "20131030", "inactive_ingredient": [ "Inactive ingredients: Cyclopentasiloxane, Stearyl Alcohol, C12-15 Alkyl Benzoate, PPG-14 Butyl Ether, Hydrogenated Castor Oil, Fragrance (Parfum), Polyethylene, Caprylic/Capric Triglyceride, Sodium Starch Octenylsuccinate, Maltodextrin, Hydrated Silica, Hydrolyzed Corn Starch, Gelatin Crosspolymer, BHT, Silica, Cellulose Gum" ], "purpose": [ "Purpose antiperspirant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on broken skin Ask a doctor before use if you have kidney disease Stop use if rash or irritation occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions? Call toll-free 1-866-334-7331" ], "spl_product_data_elements": [ "Degree Motion Sense Tropical Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY Aluminum Zirconium Tetrachlorohydrex GLY CYCLOMETHICONE 5 PPG-14 BUTYL ETHER STEARYL ALCOHOL HYDROGENATED CASTOR OIL STARCH, CORN BUTYLATED HYDROXYTOLUENE HYDRATED SILICA MALTODEXTRIN SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to underarms only" ], "stop_use": [ "Stop use if rash or irritation occurs" ], "do_not_use": [ "Do not use on broken skin" ], "package_label_principal_display_panel": [ "2.6 oz PDP DegreeMSTropicalRushPDP" ], "indications_and_usage": [ "Uses reduces underarm wetness" ], "set_id": "24d3ea41-803a-4e78-b42d-8157e74b28e6", "id": "bc826efa-82b3-4ee6-b5a7-94c0f694ffb2", "active_ingredient": [ "Active Ingredient Aluminum Zirconium Tetrachlorohydrex GLY (19.2%)" ] } ] }