Label: SUNMARK FIBER LAXATIVE- calcium polycarbophil tablet, film coated

  • 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 12/12

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 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. (1-800-222-1222)

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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.
    this product 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.
     
    age
     
    recommended dose
     
    daily maximum
     
    adults and children 12 years of age and over
     
    2 caplets once a day
     
    up to 4 times a day
     
    children under 12 years
     
    consult a physician
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  • Other information

    each caplet contains: calcium 140 mg and magnesium 10 mg
    store at 20-25 oC (68-77 oF)
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  • Inactive ingredients

    caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    COMPARE TO FIBERCON® ACTIVE INGREDIENT

    fiber laxative

    Bulk-Forming Laxative

    Fiber Therapy for Regularity

    CALCIUM POLYCARBOPHIL 625 mg

    AS EFFECTIVE AS FIBER POWDERS

    GLUTEN FREE

    Actual Size

    Fiber Laxative Carton Image 1
    Fiber Laxative Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    SUNMARK FIBER LAXATIVE 
    calcium polycarbophil tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-759
    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
    CARAMEL  
    CROSPOVIDONE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color BROWN (light) Score 2 pieces
    Shape CAPSULE (caplet) Size 19mm
    Flavor Imprint Code L477
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-759-13 1 in 1 CARTON
    1 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 09/22/2003
    Labeler - McKesson (177667227)
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