WALGREEN (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [WALGREEN COMPANY]

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WALGREEN (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [WALGREEN COMPANY]
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NDC 0363-9124-30
Set ID e7878137-a640-4d48-a6d5-23975e8b064b
Category HUMAN OTC DRUG LABEL
Packager WALGREEN COMPANY
Generic Name
Product Class
Product Number
Application Number PART335
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Anti-diarrheal / upset stomach reliever

  • 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.

  • 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 or last more than 2 days
    ▪
    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

    ▪
    chew or dissolve tablet in mouth
    ▪
    adults and children 12 years and over: 2 tablets 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
    ▪
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    ▪
    children under 12 years: ask a doctor
  • Other information

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

    flavor, magnesium stearate, maltodextrin, microcrystalline, cellulose, red #27 (Al-lake), sorbitol, sucralose.

  • Questions or comments?

    Call 1-866-467-2748

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    *Walgreen Pharmacist Recommended Walgreens Pharmacist Survey.

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

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com © 2018 Walgreen Co.

  • PRINCIPAL DISPLAY PANEL

    NDC 0363-9124-30

    Walgreens

    Soothe®

    BISMUTH SUBSALICYLATE, 262 MG

    UPSET STOMACH RELIEVER / ANTI-DIARRHEAL

    30 CHEWABLE TABLETS

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

    *Compare to Pepto-Bismol® active ingredient††

    Walgreens Bismuth Subsalicylate 30 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    WALGREEN 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9124
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9124-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/05/2019
    Labeler - WALGREEN COMPANY (008965063)
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