Label: RITE AID STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 20, 2021

If you are a consumer or patient please visit this version.

  • 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

    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 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# 11822-4320-0

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

    STOMACH RELIEF

    CHEWABLE

    BISMUTH SUBSALICYLATE 262 mg

    UPSET STOMACH RELIEVER / ANTIDIARRHEAL

    5 SYMPTOMS DIGESTIVE RELIEF:

    Heartburn
    Indigestion
    Nausea
    Upset Stomach
    Diarrhea

    CHERRY FLAVOR

    NATURALLY AND ARTIFICIALLY FLAVORED

    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’ll happily refund your money.

    IMPORTANT: Keep this carton for future reference on full labeling.

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

    RITE AID STOAMCH RELIEF CHEWABLE TABLETS
  • INGREDIENTS AND APPEARANCE
    RITE AID STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-4320-05 in 1 CARTON06/30/2020
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33506/30/2020
    Labeler - RITE AID CORPORATION (014578892)