Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Antidiarrheal/ upset stomach reliever

  • 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 or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert

    Do not use if you are

    ▪
    allergic to salicylate (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 breastfeeding, 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 to 1 hour or 4 tablets (2 doses) every hour as needed for diarrhea
    ▪
    2 tablets (1 dose) every ½ hour as needed for overindulgence (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
    ▪
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    ▪
    children under 12 years: ask a doctor
  • Other information

    ▪
    each tablet contains: salicylate 102 mg
    ▪
    Store at room temperature
    ▪
    avoid excessive heat
    ▪
    keep this carton for future reference on full labeling
  • Inactive ingredients

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

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

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

    Stomach Relief

    Chewable Tablets

    Upset Stomach Reliever/Antidiarrheal

    Original flavor

    5 Symptoms Digestive Relief:

    •
    Heartburn
    •
    Indigestion
    •
    Nausea
    •
    Upset Stomach
    •
    Diarrhea

    30 Chewable Tablets

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR OF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

    Distributed by:

    Stomach Relief BISMUTH SUBSAQLICYLATE
  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-241
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, 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
    ColorPINK (light-pink) Scoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-241-305 in 1 CARTON10/01/2020
    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 DrugM00810/01/2020
    Labeler - SAFEWAY (009137209)
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