Label: CVS STOMACH RELIEF- bismuth subsalicylate tablet

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

Drug Label Information

Updated August 16, 2024

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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 ifyou 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 producta 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 toactive 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 DrugM00808/06/2021
    Labeler - CVS (062312574)