Active Ingredient
Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)
Bismuth Chewable Tablet, Chewable
FDA Label NDC 68998-046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Bismuth Chewable (NDC 68998-046). 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, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, 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
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
If pregnant or breast feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
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
Other Information
■ Phenylketonurics: contains phenylalanine 1.1mg per tablet
■ Calcium content per tablet: 73mg
■ save carton for full directions and warnings
■ store at room temperature 15°– 30°C (59°– 86°F)
■ do not use if cellophane unit is torn
Inactive Ingredients
acacia gum, aspartame, calcium carbonate, D&C red # 27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide
Principal Display Panel
Bismuth (Bismuth 1)
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