Upset Stomach Relief
FDA Label NDC 21130-469

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Upset Stomach Relief (NDC 21130-469). 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 tablet), purpose, otc - keep out of reach of children, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Purpose

Upset stomach reliever and anti-diarrheal

Otc - Keep Out Of Reach Of Children


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 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 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 immediately.

Directions

  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea.

    • Other information: each tablet contains:

    • sodium less than 1 mg
    • salicylate 102 mg
    • calcium 140 mg
    • very low sodium
    • avoid excessive heat (over 104˚F or 40˚C)
    • TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

Inactive Ingredients

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

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*Compare to PEPTO-BISMOL® Chewable Tablets
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Upset Stomach Relief Chewable Tablets

Bismuth Subsalicylate 262 mg

Relief of: Upset Stomach, Indigestion, Nausea, Heartburn & Diarrhea

30 chewable tablets

* Please review the disclaimer below.