Label: FIBER LAXATIVE- calcium polycarbophil tablet

  • 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 November 22, 2022

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  • ACTIVE INGREDIENT (in each caplet)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

  • PURPOSE

    Bulk-forming laxative

  • USE(S)

    • relieves occasional constipation
    • 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
    • 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 DOCTOR IF

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

    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    In case of over dose, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. 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 12 years and over2 caplets, 1 to 4 times a day 
     children under 12 years  ask a doctor







  • OTHER INFORMATION

    • each caplet contains: calcium 135 mg
    • 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

    NDC 36800-465-27
    Topcare`     
    COMPARE TO FIBERCON ACTIVE INGREDIENT
    Fiber Laxative

    CALCIUM POLYCARBOPHIL 625 mg

    BULK-FORMING LAXATIVE

    • Gentle Enough for Everyday Use
    • Just as Effective as Fiber Powders

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING 
    90 CAPLETS

    81

  • INGREDIENTS AND APPEARANCE
    FIBER LAXATIVE 
    calcium polycarbophil tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-465
    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, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITE (Off white) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code G147
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-465-2790 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33408/01/2020
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(36800-465)
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