Label: KROGER 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 August 23, 2023

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 Anti-diarrheal

  • 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 older: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) 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 clear fluids to help prevent dehydration caused by diarrhea.
  • Other information

    each tablet contains: salicylate 102 mg
    store at room temperature.
    avoid excessive heat
    keep this carton for future reference on full labeling

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

  • Inactive ingredients

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

    Questions or comments?

    1-800-632-6900

  • Principal Display

    NDC# 30142-324-30

    COMPARE TO the active ingredient of PEPTO-BISMOL® CHEWABLES *See side panel

    CHEWABLE

    Stomach Relief Tablets

    Bismuth Subsalicylate 262 mg

    Upset Stomach, Reliever / Antidiarrheal

    5 SYMPTOM RELIEF

    Heartburn
    Indigestion
    Nausea
    Upset Stomach
    Diarrhea

    Original Flavor

    30 CHEWABLE TABLETS

    DISTRIBUTED BY:

    THE KROGER CO.

    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    800-632-6900

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FUL LABELING.

    *Pepto-Bismol® Chewable is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with The Kroger Co. or this product.

    Kroger Stomach Relief Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    KROGER STOMACH RELIEF 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-324
    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
    ShapeROUNDSize17mm
    FlavorImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-324-301 in 1 CARTON03/31/2020
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/31/2020
    Labeler - KROGER COMPANY (006999528)