Label: KROGER DIGESTIVE RELIEF- bismuth subsalicylate tablet, film coated

  • 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

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  • Drug Facts

    Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • PURPOSE

    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 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

    ▪
    swallow with water, do not chew
    ▪
    adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
    ▪
    do not exceed 8 doses (16 caplets) 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 caplet contains: calcium 27 mg, sodium 3 mg
    ▪
    salicylate 99 mg
    ▪
    low sodium
    ▪
    sugar free
    ▪
    store at room temperature.
  • Questions or comments?

    1-800-632-6900

    Inactive Ingredients

    calcium carbonate, crospovidone, D&C Red No. 27, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

  • PRINCIPAL DISPLAY PANEL

    NDC# 30142-524-24

    COMPARE TO the active ingredient PEPTO-BISMOL®

    *See top panel

    Kroger®

    Stomach Relief

    Bismuth Subsalicylate 262 mg

    Upset stomach Reliever/ Antidiarrheal

    5 SYMPTOMS RELIEF

    •
    Heartburn
    •
    Indigestion
    •
    Nausea
    •
    Upset Stomach
    •
    Diarrhea

    24 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.

    IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

    DISTRIBUTED BY:

    THE KROGER CO.

    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    800-632-6900

    www.kroger.com

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

    Kroger Stomach Relief 24 Counts
  • INGREDIENTS AND APPEARANCE
    KROGER DIGESTIVE RELIEF 
    bismuth subsalicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-524
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVAL (Caplet) Size16mm
    FlavorImprint Code RP125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-524-241 in 1 CARTON03/31/2020
    124 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)
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