Bismuth Subsalicylate 262 mg

FDA Drug Profile — Upset Stomach Relief-Bismuth Subsalicylate 262 mg, Bismuth Chewable

Drug Details

Generic Name
Bismuth Subsalicylate 262 mg
Brand Names
Upset Stomach Relief-Bismuth Subsalicylate 262 mg, Bismuth Chewable
Application Number
M008
Sponsor
NUVICARE LLC
NDC Codes
4
Dosage Forms
CAPSULE, LIQUID FILLED, TABLET, CHEWABLE
Routes
ORAL
Active Ingredients
BISMUTH SUBSALICYLATE

Indications and Usage

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

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.