Bismuth Subsalicylate
FDA Label NDC 70166-059

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lohxa for the product Bismuth Subsalicylate (NDC 70166-059). 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 15 ml tbsp), 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 you are taking any drug for, 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 15 Ml Tbsp)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms

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
  • an ulcer
  • a bleeding problem

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool

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  immediately.

Directions

  • shake well before use
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

  • each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104 oF or 40 oC)
  • FOR INSTITUTIONAL USE ONLY

Inactive Ingredients

benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

Principal Display (Bismuthcup 20191219 210715)

Principal Display (Bismuthcup 20191219 210715)

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