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 25, 2020

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

  • Drug Facts

  • Active ingredient (in each tablet)

    Calcium polycarbophil 625 mg (Equivalent to 500 mg polycarbophil)

    Purpose

    Bulk-forming laxative

  • Uses

    • relieves occasional constipation to help restore and maintain regularity
    • 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 tablets in a 24 hour period unless directed b y 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 or have rectal bleeding. 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 (1-800-222-1222) right away.

  • Directions

    • take this product (child or adult dose) with a full glass of water (8 oz.) 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 12 years of age and over: 2 tablets once a day up to 4 times a day
    • children under 12 years of age: ask a doctor
  • Other information

    • each tablet contains: calcium 135 mg
    • store at 20°-25°C (68°-77°F)
    • protect contents from moisture
  • Inactive ingredients

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

  • Questions?

    call toll-free 1-800-935-6737

  • Package Labeling:

    12

  • INGREDIENTS AND APPEARANCE
    FIBER LAXATIVE 
    calcium polycarbophil tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-379
    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)  
    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
    ShapeOVALSize20mm
    FlavorImprint Code G147
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54257-379-0790 in 1 BOTTLE; Type 0: Not a Combination Product01/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/24/2020
    Labeler - Magno-Humphries, Inc. (063251433)