Label: WALGREEN- bismuth subsalicylate tablet, film coated

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

Drug Label Information

Updated November 28, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplets)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever/anti-diarrheal

  • Uses

    Relieves:

    travelers’ diarrhea
    diarrhea
    upset stomach due to overindulgence in food and drink, including:
    belching
    indigestion
    gas
    fullness
    heartburn
    nausea
  • 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.

  • SPL UNCLASSIFIED SECTION

    Allergy alert: Contains salicylates. Do not take if you are:

    allergic to salicylates (including aspirin)
    taking other salicylate products
  • DO NOT USE

    Do not use if you have

    an ulcer
    a bleeding problem
    bloody or black stool
  • ASK DOCTOR

    Ask a doctor before use if you have

    fever
    mucus in the stool
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any drug for

    anticoagulation (thinning the blood)
    diabetes
    gout
    arthritis
  • WHEN USING

    When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

  • STOP USE

    Stop use and ask a doctor if

    symptoms get worse
    ringing in the ears or loss of hearing occurs
    diarrhea lasts more than 2 days
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    swallow with water; do not chew
    adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed.

    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 tablet contains: calcium 27 mg, sodium 3 mg
    salicylate 99 mg
    low sodium
    sugar free
    store at room temperature
  • Inactive ingredients

    calcium carbonate, crospovidone, D&C red # 27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

  • Questions or comments?

    Call 1-866-467-2748

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL

    NDC 0363-9125-40

    Compare to Pepto-Bismol® active ingredient††

    Soothe®

    BISMUTH SUBSALICYLATE, 262 mg/

    UPSET STOMACH RELIEVER / ANTI-DIARRHEAL

    Multi-symptom relief of nausea, heartburn, indigestion, upset stomach & diarrhea

    40 CAPLETS.

    †† Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®

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    Walgreen Soothe Bismuh Subsalicylate 262 mg
  • INGREDIENTS AND APPEARANCE
    WALGREEN 
    bismuth subsalicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9125
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    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
    ShapeOVALSize16mm
    FlavorImprint Code RP125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9125-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00805/14/2019
    Labeler - WALGREEN CO. (008965063)