QC STOMACH RELIEF CHERRY FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • QC STOMACH RELIEF CHERRY FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

QC STOMACH RELIEF CHERRY FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-305-08
Set ID d019eef1-8817-4bd4-84cf-04fd6542ee1a
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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  • Active ingredient (in each 30 mL dose cup)

    Bismuth subsalicylate 525 mg

  • Purposes

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves

    •
    travelers’ diarrhea
    •
    diarrhea
    •
    upset stomach due to overindulgence in food and drink, including:
    •
    heartburn
    •
    indigestion
    •
    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 or 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 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 (30 mL) every 1/2 to 1 hour as needed
    •
    do not exceed 8 doses (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 30 mL contains: sodium 10 mg
    •
    salicylate 261 mg
    •
    low sodium
    •
    sugar free
    •
    store at room temperature
    •
    protect from freezing
    •
    avoid excessive heat (more than 104°F 40°C)
  • Inactive ingredients

    carboxymethylcellulose sodium, D&C Red # 22, D&C Red # 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

    Do not use if imprinted shrink band is missing or broken.

  • Principal Display Panel

    Quality Choice®

    NDC# 63868-305-08

    Compare To the Active Ingredient PEPTO-BISMOL® Regular Strength

    Pink Bismuth

    Stomach Relief

    Bismuth Subsalicylate 525 mg

    Soothing Relief from:

    Upset Stomach

    Indigestion

    Nausea

    Heartburn

    Diarrhea

    Regular Strength

    Cherry Flavor

    8 FL. OZ. (236 mL)

    100% QC SATISFACTION GURANTEE

    Distributed by C.D.M.A., Inc.©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

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

    QC(CDMA) Pink Bismuth Stomach Relief Cherry Flavor
  • INGREDIENTS AND APPEARANCE
    QC STOMACH RELIEF  CHERRY FLAVOR
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-305
    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 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-305-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2019
    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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