QUALITY CHOICE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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QUALITY CHOICE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-530-90
Set ID f1e69c65-c1b0-459f-9a12-b1a92b90036b
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Generic Name
Product Class
Product Number
Application Number PART334
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  • Drug Fats

    Active Ingredient (in each caplet)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

  • PURPOSE

    PURPOSE

    Bulk-forming fiber laxative

  • USES

    •
    relieves occasional constipation to help restore and maintain regularity
    •
    this product generally produces bowel movement in 12 to 72 hours
  • WARNINGS

    Choking Warning: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

    Ask a doctor before use if you have

    •
    abdominal pain, nausea, or vomiting
    •
    a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

    When using this product

    •
    do not use for more than 7 days unless directed by a doctor
    •
    do not take more than 8 tablets in a 24 hour period unless directed by a doctor

    Stop use and ask a doctor if

    rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

    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

    •
    Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
    •
    This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

    Age

    Recommended

    Daily maximum

    adults & children 12 years of age and over

    2 caplets once a day

    up to 4 times a day

    children under 12 years

    consult a physician
  • OTHER INFORMATION

    •
    each caplet contains: calcium 125 mg
    •
    do not use if imprinted safety seal under cap is broken or missing
    •
    store at 20-25°C (68-77°F)
    •
    protect contents from moisture
  • INACTIVE INGREDIENT

    calcium carbonate, caramel, crospovidone, hypromellose, microcrystalline cellulose, maltodextrin, magnesium stearate, polyethylene glycol, silica, sodium lauryl sulfate.

  • Questions or Comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC# 63868-530-90

    QUALITY CHOICE®

    Compare to Fibercon® active ingredients*

    Fiber Caplets

    Calcium Polycarbophil 625 mg

    Bulk-Forming

    Fiber Laxative

    Gentle Relief of Constipation Won’t Cause Gas or Bloating

    90 Tablets

    100% QC SATISFACTION GURANTEED

    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 Pfizer Consumer Healthcare, the distributor of Fibercon®

    QC(CDMA) Fiber Caplets
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARAMEL (UNII: T9D99G2B1R)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code RP120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-530-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/16/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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