Rite Aid Stomach Relief Tablet, Chewable
FDA Label NDC 11822-2430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Stomach Relief (NDC 11822-2430). 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 antidiarrheal

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. Do not swallow tablets whole.
  • adults and children 12 years and over:
  • ▪2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • ▪2 tablets (1 dose) every ½ hour as needed for over indulgence (upset stomach, heartburn, indigestion, nausea.
  • ▪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 tablet contains: salicylate 102 mg
  • ▪store at room temperature.
  • ▪avoid excessive heat
  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Inactive Ingredients

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display

NDC# 11822-2430-0

Compare to the active ingredient in Pepto-Bismol® Chewables*

Stomach Relief

Chewable Tablets

Bismuth Subsalicylate

Upset Stomach Reliever / Antidiarrheal

5 Symptoms Digestive Relief:

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea
  • Original Flavor

    30 Chewable Tablets

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE,

    CAMP HILL, PA 17011

    www.riteaid.com

    SATISFACTION GUARANTEE

    If you’re not satisfied, we will happily refund your money.

    IMPORTANT: Keep this carton for future labeling.

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

    Rite Aid Stomach Relief Chewable Tablets (172gnp)

    Rite Aid Stomach Relief Chewable Tablets (172gnp)

* Please review the disclaimer below.