Label: FIBER LAXATIVE- calcium polycarbophil tablet, film coated

  • NDC Code(s): 57896-459-09
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 18, 2020

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

  • Active ingredient (in each caplet)

    Calcium Polycarbophil 625 mg

    (equivalent to 500 mg polycarbophil)

  • Purpose

    Bulk-forming laxative

  • Uses

    • relieves occasional constipation
    • promotes regularity
    • this product generally produces a 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 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 caplets 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.

  • 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 laxative 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.
    adults and children 12
    years of age and older
    Starting dose: 2 caplets once a day
    Maximum dose: 2 caplets four times a day or as directed by a doctor
    children under 12 years of ageconsult a doctor
  • Other information

    each caplet contains: calcium 138 mg

    • store at controlled room temperature, 68°F-77°F (20°C-25°C)

    • protect contents from moisture

    • for institutional use only

    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

  • Inactive ingredients

    caramel, cellulose, crospovidone, hypromellose,
    magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium
    lauryl sulfate, stearic acid. May also contain calcium carbonate, croscarmellose
    sodium, maltodextrin, talc.

  • Package Label

    gc

  • INGREDIENTS AND APPEARANCE
    FIBER LAXATIVE 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-459
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    CARAMEL (UNII: T9D99G2B1R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorwhite (Off white to cream) Score2 pieces
    ShapeOVAL (Caplet) Size19mm
    FlavorImprint Code CPC;339
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-459-0990 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)