QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR (BISMUTH SUBSALICYLATE) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-339-12
Set ID 02737763-eb98-401d-942c-186c401a2d31
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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per 15 ml)

    Bismuth subsalicylate 262 mg

  • Purposes

    Antidiarrheal/Upset stomach reliever

  • Uses

    Relieves

    ▪
    traveler’s diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink
    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    gas
  • 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

    ▪
    diabetes
    ▪
    gout
    ▪
    arthritis
    ▪
    anticoagulation (thinning the blood)

    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 at 1-800-222-1222.

  • Directions

    ▪
    shake well immediately before each use
    ▪
    adults and children 12 years of age and older : 30 ml or 2 tablespoonful
    ▪
    for accurate dosing, use convenient pre-measured dose cup
    ▪
    repeat dose every 1/2 hour to 1 hour as needed
    ▪
    do not exceed 8 doses 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 15mL tablespoon contains: sodium 10 mg
    ▪
    each 15mL tablespoon contains: salicylate 130 mg
    ▪
    do not use if printed inner seal is broken or missing
    ▪
    store at room temperature
  • Inactive ingredients

    caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

    NDC 63868-339-12

    Compare to the active ingredient in Kaopectate®

    Diarrhea Relief

    Bismuth Subsalicylate, 262 mg

    Bismuth Subsalicylate, 262 mg

    Antidiarrheal

    Upset Stomach Reliever

    Effective Diarrhea Relief

    Restores Natural Balance

     
    Vanilla Regular Flavor

    12 FL OZ (355 mL)

    100% SATISFACTION GUARANTEED

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

    43157 W. Nine Mile

    Novi. MI 48376-0995

    www.qualitychoice.com

    Question: 248-449-9300

    *This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

    QC(CDMA) Bismuth Subsalicylate Diarrhea Relief
  • INGREDIENTS AND APPEARANCE
    QC ANTI DIARRHEAL  VANILLA REGULAR FLAVOR
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-339
    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
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    salicylic acid (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorVANILLA (Regular) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-339-12355 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 finalpart33504/16/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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