Label: QC STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

  • NDC Code(s): 63868-304-08, 63868-304-12
  • Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Active ingredient (in each 15 mL)

    Bismuth subsalicylate 525 mg

  • Purpose

    Upset stomach reliever/Antidiarrheal

  • Uses

    relieves

    •
    travelers' diarrhea
    •
    diarrhea
    •
    upset stomach due to overindulgence in food and drink, including:
    •
    heartburn
    •
    indigestion
    •
    upset stomach
    •
    nausea
    •
    gas
    •
    belching
  • 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
    •
    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 right away. (1-800-222-1222)

  • Directions

    •
    shake well before use
    •
    For accurate dosing, use dose cup
    •
    adults and children 12 years and over:
    •
    1 dose (2 tbsp. or 30 ml) every 1 hour as needed
    •
    do not exceed 4 doses (8tbsp or 120 mL) 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 tbsp. contains: sodium 10 mg
    •
    low sodium
    •
    sugar free
    •
    salicylate 236 mg
    •
    protect from freezing
    •
    avoid excessive heat (more than 104ºF or 40ºC)
    •
    TAMPER EVIDENT: Do not use if imprinted shrink band is missing or broken
  • Inactive ingredients

    Carboxymethylcellulose sodium, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, red 22, red 28, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum.

  • Principal Display Panel

    Compare to the active ingredient in Pepto-Bismol® Maximum Strength

    Pink Bismuth

    Maximum Strength

    Stomach Relief

    Bismuth Subsalicylate 525 mg

    Soothing Relief from:

    Upset Stomach

    Indigestion Nausea

    Heartburn

    Diarrhea

    Original Flavor

    FL OZ (mL)

    QC SATISFACTION GURANTEED

    *This product is not manufactured or distributed by The Procter & Gamble, distributors of Pepto-Bismol®.

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

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    QC(CDMA) Maximum Strength Pink Bismuth Subsalicylate525mg
  • Package Label

    QC(CDMA) Maximum Strength Pink Bismuth Subsalicylate525mg

    Maximum Strength Stomach Relief

  • INGREDIENTS AND APPEARANCE
    QC STOMACH RELIEF  REGULAR STRENGTH
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-304
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-304-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2019
    2NDC:63868-304-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/16/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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