Pepto Relief
Pepto Relief is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE manufactured by Advance Pharmaceutical Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20171222.
Generic: BISMUTH SUBSALICYLATE
Manufacturer: Advance Pharmaceutical Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 17714-045
Application: part335
Effective: 20171222
Active Ingredients: Active Ingredient (in each tablet) Bismuth subsalicylate 262 mg
Indications & Usage
Uses Controls diarrhea Relieves upset stomach due to overindulgence in food or drink
Dosage & Administration
Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea repeat dosage every 1/2 to 1 hour as needed do not take more than 8 doses in 24 hours use until diarrhea stops but not more than 2 days adults and children 12 years and over: 2 tablets children under 12 years: ask a doctor
Contraindications
Not available.
Warnings
Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use If you have bloody or black stool If you have an ulcer or bleeding problem Ask a doctor before use if you have Fever Mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis when using this product a temporary, but harmless, darkening of the stool and/or tongue may occur 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 If pregnant or breast-feeding, ask a health professional before use.
Adverse Reactions
Not available.
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