Label: FIBER TABS- calcium polycarbophil tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 09/12

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

  • DRUG FACTS
  • ACTIVE INGREDIENT (IN EACH TABLET)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

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  • PURPOSE

    Bulk-forming fiber laxative

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  • USES

    • relieves occasional constipation to help restore and maintain regularity
    • this product generally produces 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.

    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.

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  • 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.
    • Do not take more than 4 doses in 24 hours
    age recommended dose daily maximum
     adults and children 12 years of age and over  2 tablets  1 to 4 times a day
     children under 12 years  consult a physician   
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  • OTHER INFORMATION

    • each tablet contains: 140 mg calcium
    • protect contents from moisture
    • store at room temperature, USP
    • do not use if imprinted safety seal under cap is broken or missing
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS OR COMMENTS?

    To report side effects call: 1-800-616-2471

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  • PRINCIPAL DISPLAY PANEL

    Fiber-Tabs

    Calcium Polycarbophil Bulk-Forming Fiber Laxative

    90 Tablets

    Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150  USA

    Fiber-Tabs

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  • INGREDIENTS AND APPEARANCE
    FIBER TABS 
    calcium polycarbophil tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-2500
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) POLYCARBOPHIL 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL  
    CELLULOSE, MICROCRYSTALLINE  
    CROSPOVIDONE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    SODIUM LAURYL SULFATE  
    MAGNESIUM SILICATE  
    LIGHT MINERAL OIL  
    12-HYDROXYSTEARIC ACID  
    Product Characteristics
    Color GRAY (Off white to grayish color depending on lighting) Score 2 pieces
    Shape OVAL Size 20mm
    Flavor Imprint Code CPC;339
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-2500-91 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part334 09/09/2010
    Labeler - Major Pharmaceuticals (191427277)
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