Label: FIBERCON- calcium polycarbophil tablet

  • NDC Code(s): 80070-500-14, 80070-500-90
  • Packager: Foundation Consumer Brands
  • 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 April 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

  • Purpose

    Bulk-forming laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • this product generally produces bowel movement in 12 to 72 hours
  • 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 lasts 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

    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.

  • 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.
    • adults and children 12 years of age and over: 2 caplets per dose. Do not take more than 8 caplets in 24 hours unless directed by a doctor.
    • children under 12 years of age: ask a doctor
  • 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 ingredients

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

  • Questions or comments?

    Call 1-888-594-0677 weekdays 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: Foundation Consumer Brands, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Carton

    FiberCon®

    Calcium Polycarbophil
    Bulk-Forming Laxative

    Fiber Therapy for Irregularity

    90 Caplets

    PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FIBERCON 
    calcium polycarbophil tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-500
    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 (120 .MU.M) (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:80070-500-141 in 1 CARTON04/15/2021
    1140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:80070-500-901 in 1 CARTON04/15/2021
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/15/2021
    Labeler - Foundation Consumer Brands (117603632)
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