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Drug Facts
Allergy alert: Contains salicylates. Do not take if you are:
▪ allergic to salicylates (including aspirin)▪ taking other salicylate products
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
Walgreen Tablet, Film Coated
FDA Label NDC 0363-9125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreen (NDC 0363-9125). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each caplets), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplets)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever/anti-diarrheal
Uses
Relieves:
▪ travelers’ diarrhea▪ diarrhea▪ upset stomach due to overindulgence in food and drink, including:▪ belching▪ indigestion▪ gas▪ fullness▪ heartburn▪ nausea
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Otc - Do Not Use
Do not use if you have
▪ an ulcer▪ a bleeding problem▪ bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
▪ fever▪ mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
▪ anticoagulation (thinning the blood)▪ diabetes▪ gout▪ arthritis
Otc - When Using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
Otc - Stop Use
Stop use and ask a doctor if
▪ symptoms get worse▪ ringing in the ears or loss of hearing occurs▪ diarrhea lasts more than 2 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 at 1-800-222-1222.
Directions
▪ swallow with water; do not chew▪ adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed.Do not exceed 8 doses (16 tablets) in 24 hours.
▪ use until diarrhea stops, but not more than 2 days▪ children under 12 years: ask a doctor▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
▪ each tablet contains: calcium 27 mg, sodium 3 mg▪ salicylate 99 mg▪ low sodium▪ sugar free▪ store at room temperature
Inactive Ingredients
calcium carbonate, crospovidone, D&C red # 27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.
Questions Or Comments?
Call 1-866-467-2748
Package Label.Principal Display Panel
NDC 0363-9125-40
Compare to Pepto-Bismol® active ingredient††
Soothe®
BISMUTH SUBSALICYLATE, 262 mg/
UPSET STOMACH RELIEVER / ANTI-DIARRHEAL
▪ Multi-symptom relief of nausea, heartburn, indigestion, upset stomach & diarrhea
40 CAPLETS.
†† Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®
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Walgreen Soothe Bismuh Subsalicylate 262 mg (Image 01)
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