Bismuth
FDA Label NDC 53807-152

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Bismuth (NDC 53807-152). 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 (in each tablespoon= 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablespoon= 15 Ml)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

  • relieves upset stomach due to overindulgence in food or drink
  • controls diarrhea

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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
  • if you have an ulcer or bleeding problem

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool
  • a magnesium-restricted diet
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking any 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 more than 2 days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center  right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • shake well before using
  • use pre-measured cup for accurate dosing
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults & children 12 years and over: 2 tablespoons
  • children under 12 years: ask a doctor

Inactive Ingredients

Carboxymethylcellulose sodium, D&C Red #3, FD&C Red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water

Storage And Handling

  • Store at room temperature. Protect from freezing and excessive heat (over 40oF or 104oC)
  • each tablespoon (15 mL) contains: magnesium 32 mg
  • each tablespoon (15 mL) contains: sodium 24 mg
  • each tablespoon (15 mL) contains: total salycylate 159 mg
  • TAMPER EVIDENT:Do not use if printed inner cap seal is broken or missing..

Principal Display Panel

Bismuth Label (M527)

Bismuth Label (M527)

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