Label: QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF- bismuth subsalicylate suspension

  • 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 January 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient(in each 15 ml Tablespoon)

    Bismuth subsalicylate 262 mg

  • Purposes

    Upset stomach reliever and 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.

  • 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 ½ to 1 hour as needed
    ▪
    do not exceed 8 doses (16 tbsp or 240 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 6 mg
    ▪
    low sodium
    ▪
    sugar free
    ▪
    salicylate 130 mg
    ▪
    protect from freezing
    ▪
    avoid excessive heat (more than 104°F or 40°C)
    ▪
    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 - 236 mL Bottle Label

    QC

    Quality Choice®

    NDC 63868-303-08

    *Compare to the active ingredient in PEPTO-BISMOL® Regular strength

    PINK BISMUTH

    Stomach Relief

    Bismuth Subsalicylate 262mg

    Soothing Relief from:

     
    Upset Stomach
     
    Indigestion, Nausea
     
    Heartburn
    •
    Diarrhea
    NaN
    Original Flavor

    8 FL OZ (236 mL)

    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, distributors of Pepto-Bismol®.

    Quality Choice Pink Bismuth Stomach Relief Original flavor 8 FL OZ 236mL
  • INGREDIENTS AND APPEARANCE
    QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF 
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE) Bismuth subsalicylate262 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
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-303-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/23/2015
    Labeler - Chain Drug Manufacturing Assn (011920774)
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