bismuth subsalicylate

FDA Drug Profile — Kaopectate Vanilla Flavor Anti Diarrheal, Thompson Chewable Bismuth Tabs, Kaopectate Peppermint Flavor Anti Diarrheal, WONDERBELLY MULTI-SYMPTOM, Kaopectate Max Peppermint Flavor Anti Diarrheal

Drug Details

Generic Name
bismuth subsalicylate
Brand Names
Kaopectate Vanilla Flavor Anti Diarrheal, Thompson Chewable Bismuth Tabs, Kaopectate Peppermint Flavor Anti Diarrheal, WONDERBELLY MULTI-SYMPTOM, Kaopectate Max Peppermint Flavor Anti Diarrheal, Wonderbelly Multi-Symptom, McKesson Bismuth
Application Number
M008
Sponsor
Kramer Laboratories
NDC Codes
8
Dosage Forms
LIQUID, TABLET, CHEWABLE
Routes
ORAL
Active Ingredients
BISMUTH SUBSALICYLATE

Indications and Usage

Use temporarily relieves: controls diarrhea relieves heartburn, indigestion, nausea and upset stomach without constipating

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 Warning 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 prescription drug for: anticoagulation (thinning of the blood) diabetes gout arthritis Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than two days When using this product: a temporary, but harmless darkening of the stool and/or tongue may occur. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center right away.