Label: CALCIUM POLYCARBOPHIL tablet, film coated

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

Drug Label Information

Updated January 23, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (in each caplet)

    Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

  • PURPOSE

    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

    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
    do not take more than 8 caplets in a 24-hour period unless directed by a doctor

    Stop use and ask a doctor if

    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 (1-800-222-1222) 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 may cause choking. See choking warning.
    dosage will vary according to diet, exercise, previous laxative use or severity of constipation
    continued use for 1 to 3 days is normally required to provide full benefit

    adults and children 12 years and over2 caplets, 1 to 4 times per day
    children under 12 yearsask 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

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

    ©2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313

    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.

  • PRINCIPAL DISPLAY PANEL

    LEADER

    NDC 70000-0067-1

    Fiber Laxative + Calcium

    Calcium Polycarbophil, 625 mg

    Bulk-Forming Laxative

    Fiber Therapy for Regularity

    COMPARE TO FIBERCON® active ingredient*

    250 Caplets

    Cardinal Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM POLYCARBOPHIL 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0067
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Colorwhite (off white) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code CPC;339
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0067-1250 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/18/2020
    Labeler - Cardinal Health (063997360)