Label: FIBER LAXATIVE - calcium polycarbophil tablet 

  • NDC Code(s): 57896-449-09
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/13

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)

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  • Purpose

    Bulk-forming laxative

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  • Uses

    • relieves occasional constipation
    • promotes regularity
    • this product generally produces a bowel movement in 12 to 72 hours
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  • 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.


    Do not use
    • for more than 1 week unless directed by a doctor

    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

    • all laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    • you have rectal bleeding

    • you have no bowel movement within 3 days

    • 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.

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  • Directions

    • do not exceed recommended dose

    • take each dose with at least 8 ounces (a full glass) of fluid; taking this product without enough liquid may cause choking; see choking warning

    • do not take this product within 2 hours before or after taking any other drug

    adults and children 12
    years of age and older
    Starting dose: 2 caplets once a day
    Maximum dose: 2 caplets four times a day
    Starting dose: 2 caplets once a day
    Maximum dose: 2 caplets four times a day
    consult a doctor
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  • Other information

    each caplet contains: calcium 125 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.

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  • Inactive ingredients

    caramel color, croscarmellose sodium, hypromellose, microcrystalline cellulose, PEG, silica, talc

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  • Package Label

    GERICARE

    NDC 57896-449-09
    Fiber Laxative
    Calcium Polycarbophil

    • Relieves Constipation

    • Promotes Regularity

    90 Caplets

    625 mg Each

    Compare to active ingredient

    in FiberCon®*

    Fiber Laxative label

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  • INGREDIENTS AND APPEARANCE
    FIBER LAXATIVE 
    calcium polycarbophil tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57896-449
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL 625 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    SILICON DIOXIDE  
    TALC  
    CARAMEL  
    Product Characteristics
    Color brown (Off white with dark brown specks) Score no score
    Shape OVAL (Caplet) Size 20mm
    Flavor Imprint Code AZ221
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-449-09 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/01/2004
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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