Label: CALCIUM POLYCARBOPHIL tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • Drug Facts

    Active ingredient (in each caplet)

    Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

  • Purpose

    Bulk-forming laxative

  • Uses

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 12 to 72 hours

  • WARNINGS

    Choking: 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

    difficulty in swallowing

    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 two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product

    do not use for more than 7 days unless directed by a doctor

    Stop use and ask a doctor if

    you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing

    you fail to have a bowel movement after use or have rectal bleeding. 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.

  • Directions

    take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my cause choking. See choking warning.

    adults and children over 12 years of age and over2 caplets, 1 to 4 times per day. Do not take more than 8 caplets in 1 24-hour period unless directed by a doctor.
    children under 12 years of ageask a doctor

  • Other information

    each caplet contains: calcium 140 mg

    do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
    protect contents from moisture

  • INACTIVE INGREDIENT

    Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov

    *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark FiberCon®

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2023 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

  • PRINCIPAL DISPLAY PANEL

    CVS

    Health

    Compare to the active ingredient in FiberCon®*

    Fiber Laxative

    Plus Calcium

    Calcium Polycarbophil 625 mg

    Bulk-Forming Laxative

    Fiber Therapy for regularity

    250 Caplets

    CVS Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM POLYCARBOPHIL 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-846
    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
    CARAMEL (UNII: T9D99G2B1R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorwhite (off white) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code CPC;339
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-846-02250 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/17/2021
    Labeler - CVS Pharmacy, Inc (062312574)
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