QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CHAIN DRUG MANUFACTURING ASSN]

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QC QUALITY CHOICE PINK BISMUTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [CHAIN DRUG MANUFACTURING ASSN]
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NDC 63868-303-12
Set ID bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Manufacturing Assn
Generic Name
Product Class
Product Number
Application Number PART335
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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 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 - 354 mL Bottle Label

    QC

    Quality Choice®

    NDC 63868-303-12

    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
     
    ORIGINAL FLAVOR

    12 FL OZ (354 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 12 FL OZ 354 mL
  • 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 FORM (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:63868-303-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/20/2015
    Labeler - Chain Drug Manufacturing Assn (011920774)
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