Cvs Health Stomach Relief Tablet, Chewable
FDA Label NDC 69842-221

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Stomach Relief (NDC 69842-221). 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, 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.

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

Uses

relieves:

  • ▪travelers’ diarrhea
  • ▪diarrhea
  • ▪upset stomach due to overindulgence in food and drink, including:
  • ▪heartburn
  • ▪indigestion
  • ▪nausea
  • ▪gas
  • ▪belching
  • ▪fullness

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

  • ▪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 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 or last more than 2 days
  • ▪ringing in the ears or loss of hearing occurs
  • ▪diarrhea lasts more than 2 days

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Directions

  • ▪chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older: 2 tablets every 1/2 to 1 hour as needed
  • ▪do not exceed 8 doses (16 tablets) in 24 hours
  • ▪use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • ▪drink plenty clear fluids to help prevent dehydration caused by diarrhea.

Other Information

  • each caplet contains: salicylate 102 mg
  • ▪avoid excessive heat (over 104°F or 40°C)
  • ▪keep this carton for future reference on full labeling
  • TAMPER EVIDENT: DO NOT USE IF THE ADHESIVE LABELS AROUND THE BOTTLE CAP IS TORN, BROKEN OR MISSING.

Inactive Ingredients

flavor, magnesium stearate, microcrystalline cellulose, red # 27 aluminum lake, sorbitol, sucralose.

Questions?

1-866-467-2748

Principal Display

CVS Health

NDC# 69842-221-12

Compare To the active ingredient in Pepto-Bismol® Tablets*

Cherry Flavor

Original TWIN PACK

Stomach relief

BISMUTH SUBSALICYLATE 262 mg

Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:

  • Heartburn
  • Indigestion Nausea
  • Upset stomach
  • Diarrhea
  • 2-12 COUNT BOTTLES

    24 CHEWABLE TABLETS TOTAL

    Cherry Flavor

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2016 CVS/pharmacy

    CVS.com 1-800-SHOP CVS

    V-16415

    *This product is not manufactured or distributed by The Procter & Gamble Co., the distributor of Pepto-Bismol®.

    Cvs Health Cherry Flavor Bismuth Subsalicylate 24 Chewable Tablets (172gnp)

    Cvs Health Cherry Flavor Bismuth Subsalicylate 24 Chewable Tablets (172gnp)

* Please review the disclaimer below.