Label: FIBERCON- calcium polycarbophil tablet

  • NDC Code(s): 0005-2500-02, 0005-2500-23, 0005-2500-33
  • Packager: Wyeth Pharmaceutical Division of Wyeth Holdings LLC
  • 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 December 4, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)Purpose
    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophilBulk-forming laxative
  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation to help restore and maintain regularity
    • this product generally produces bowel movement in 12 to 72 hours
  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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.
    • FiberCon 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.
    agerecommended dosedaily maximum
    adults and children 12 years of age and over2 caplets once a dayup to 4 times a day
    children under 12 yearsconsult a physician 
  • SPL UNCLASSIFIED SECTION

    Other information

    • each caplet contains: 140 mg calcium and 10 mg magnesium
    • protect contents from moisture
    • store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM to 5 PM EST at 1-800-282-8805

  • PRINCIPAL DISPLAY PANEL - 36 Caplet Blister Pack Carton

    FiberCon®

    Calcium Polycarbophil Bulk-Forming Laxative

    Fiber Therapy for Regularity


    • Gentle Enough for
      Everyday Use*
    • Won't Ferment to
      Cause Gas or Bloating
    • As Effective as
      Fiber Powders

    *when used as directed

    CONVENIENT
    TRAVEL PACK!

    36 Caplets

    Principal Display Panel - 36 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    FIBERCON 
    calcium polycarbophil tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0005-2500
    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
    CARAMEL (UNII: T9D99G2B1R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code LL;F1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0005-2500-029 in 1 CARTON01/05/2004
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0005-2500-331 in 1 CARTON01/05/2004
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0005-2500-23140 in 1 BOTTLE; Type 0: Not a Combination Product01/05/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/05/2004
    Labeler - Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)