Label: CVS STOMACH RELIEF- bismuth subsalicylate tablet

  • 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 September 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

    Uses

    relieves

    •
    traveler’s 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

    •
    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 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 occurs 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.1-800-222-1222.

  • Directions

    •
    chew or dissolve tablets in mouth. Do not swallow tablets whole.
    •
    adults and children 12 years and older: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 dose) every hour as needed for diarrhea
    •
    2 tablets (1 dose) every 1/2 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
    •
    children under 12 years: ask a doctor
    •
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    •
    each tablets contains: salicylate 102 mg
    •
    store at room temperature
    •
    avoid excessive heat
  • Inactive ingredients

    D&C Red# 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC 51316-124-48

    Compare to active ingredient in Pepto-Bismol® Chewables*

    Stomach Relief

    Chewable tablets

    Bismuth subsalicylate, Upset Stomach Reliever / Antidiarrheal

    5- symptom digestive relief

    •
    Upset stomach,
    •
    Nausea,
    •
    Heartburn,
    •
    Indigestion,
    •
    Diarrhea
     
    Original flavor

    48 chewable tablets

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

    Dist.by

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

    CVS stomach relief bismuth subsalicylate
  • INGREDIENTS AND APPEARANCE
    CVS STOMACH RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-124
    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
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-124-4848 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33508/06/2021
    Labeler - CVS (062312574)
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