Bismuth Chewable

BISMUTH SUBSALICYLATE 262 MG ORAL HUMAN OTC DRUG

Bismuth Chewable is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE 262 MG manufactured by Marc Glassman, 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 20161219.

Generic name
BISMUTH SUBSALICYLATE 262 MG
Manufacturer
Marc Glassman, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
68998-046
Application
M008
Label effective
20161219

Active ingredients

Active ingredient Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Indications & Usage

Uses ■ controls diarrhea ■ relieves heartburn, indigestion, nausea and upset stomach

Dosage & Administration

Directions ■ drink plenty of clear fluids to help revent deydration caused by diarrhea ■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed ■ do not exceed 16 tablets in 24 hours ■ use until diarrhea stops but no more than 2 days ■ Children under 12 years of age: 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: Contains salicylate. 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 ■ an ulcer ■ a 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 a drug for ■ anticoagulation (thinning of 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 for more than 2 days Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Adverse Reactions

Not available.