Label: FIBERCON- calcium polycarbophil tablet

  • NDC Code(s): 80070-500-14
  • Packager: Foundation Consumer Brands
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 1, 2024

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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 aretaking 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 productdo not use for more than 7 days unless directed by a doctor

    Stop use and ask a doctor ifrectal 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 chokingwarning.
    • 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, mineral oil, polyethylene glycol, silicon dioxide, sodium lauryl sulfate, stearic acid, talc

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

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

    WARNING: Reproductive Harm - www.P65warnings.ca.gov

  • PRINCIPAL DISPLAY PANEL - 140 Caplet Bottle

    NEW FORMULA

    FiberCon ®

    Calcium Polycarbophil
    Bulk-Forming Laxative

    Simple Relief for Constipation

    • Won't cause gas or bloating
    • As effective as fiber powders

    140 Coated Caplets

    Fibercon 140ct bottle

  • 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
    TALC (UNII: 7SEV7J4R1U)  
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorbrownScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code LL;F1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80070-500-14140 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/04/2021
    Labeler - Foundation Consumer Brands (117603632)
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