Label: FIBER CAPS- calcium polycarbophil tablet, film coated

  • 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 January 17, 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:

    • constipation
    • helps restore and maintain regularity
    • promotes normal function of the bowel
    • this product generally produces bowel movement in 12 to 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • 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
    • difficulty in swallowing
    • 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

    • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
    • you fail to have a bowel movement after use
    • rectal bleeding occurs

  • 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 over 12 years
    2 caplets, 1 to 4 times a day
    children under 12 years
    ask a doctor

  • Other information

    • each caplet contains: calcium 135 mg
    • do not use if printed seal under cap is torn or missing
    • store at room temperature
    • protect contents from moisture
  • Inactive ingredients

    calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

  • Principal Display Panel

    Compare to the active ingredient in FIBERCON

    NDC 53041-147-27

    Stimulant Free

    Fiber-Caps

    Fiber Laxative

    Calcium polycarbophil 625 mg

    • Relieves constipation
    • Helps Restore and Maintain Regularity

    image description

  • INGREDIENTS AND APPEARANCE
    FIBER CAPS  
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-147
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARAMEL (UNII: T9D99G2B1R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorwhite (off white with black specks) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code G147
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-147-2790 in 1 BOTTLE; Type 0: Not a Combination Product07/15/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/15/2010
    Labeler - Guardian Drug Company (119210276)