QC PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, FILM COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • QC PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, FILM COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

QC PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, FILM COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-171-40
Set ID f69f5164-f227-4527-ac1c-cda213b96b25
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Generic Name
Product Class
Product Number
Application Number PART335
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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?

    1-866-467-2748

    Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    NDC# 63868-171-40

    Compare to Pepto-Bismol® Regular Strength the active ingredient*

    Pink Bismuth

    Stomach Relief

    Bismuth Subsalicylate 262mg

    Upset stomach Indigestion, Nausea, Heartburn, Diarrhea

    Package Contains One Bottle

    40 Caplets

    QC SATISFACTION GUARANTEED

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

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

    QC(CDMA) Pink Bismuth Subsalicylate 262 mg
  • INGREDIENTS AND APPEARANCE
    QC PINK BISMUTH 
    bismuth subsalicylate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-171
    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, 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
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-171-401 in 1 CARTON04/15/2019
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33504/15/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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