Bismutina Liquid
FDA Label NDC 53145-475

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Bismutina (NDC 53145-475). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Bismuth Subsalicylate 525 mg

Otc - Purpose

Purpose

Upset Stomach Reliever and Antidiarrheal

Indications & Usage

Uses

relieves

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching

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 there 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 

    • an ulcer
    • a bleeding problem
    • bloody or black stool

      • 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

          • When using this product, a temporary, but harmless, darking of the stool and/or tongue may occur.

          Stop use and ask a doctor if

          • symptoms get worse or last for more than two days
          • ringing in the ears or loss of hearing occurs
          • diarrhea lasts more than 2 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • drink plenty of clear fluids to help prevent dehydration cause by diarrhea
  • shake well before use
  • adults and children 12 years of age and over:
  • 2 tablespoonfuls (30 mL) every 1/2 hour or 4 tablespoonfuls (60 mL) every hour as needed for diarrhea/traveler's diarrhea  
  • 2 tablespoonfuls (30 mL) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablesproonfuls or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • Children under 12 years: ask a doctor

Inactive Ingredient

Inactive ingredients

benzoic acid, citric acid, FD&C yellow #5, flavor, salicylic acid, sodium citrate, sodium salicylate, sorbic acid, sucralose, water, xanthan gum

Otc - Questions

Questions? call 1-800-560-5223 M-F 9 AM to 5 PM Eastern Time

Package Label.Principal Display Panel

Bismutina (Bismutina)

Bismutina (Bismutina)

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