Active Ingredient
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
Bismuth Tablet
FDA Label NDC 69168-046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Bismuth (NDC 69168-046). 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 active ingredient, purpose, uses, reye’s syndrome, allergy alert, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal/Antacid
Uses
controls diarrhea relieves heartburn, indigestion, nausea and upset stomach without constipating
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 any drug for anticoagulation (thinning 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 2 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 immediately.
Directions
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Adults and Children 12 years and over: 525 mg ( 2 tablets) every ½ to 1 hour or 1050 mg (4 tablets) every hour as needed do not exceed 4200 mg ( 16 tablets) in 24 hours use until diarrhea stops but not more than 2 days
Children under 12 years: ask a doctor
Inactive Ingredients
aspartame, calcium carbonate, , D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide
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