Label: FIBER TABS- calcium polycarbophil tablet, film coated

  • 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 May 18, 2020

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

  • Drug Fats

    ACTIVE INGREDIENT (IN EACH TABLET)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

  • PURPOSE

    PURPOSE

    Bulk-forming fiber laxative

  • USES

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

    Choking Warning: 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 tablets 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.

  • DIRECTIONS

    Take 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). Do not take more than 4 doses in 24 hours

    adults & children over 12 years of age: take 2 tablets 1 to 4 times a day

    children under 12 years of age: consult a physician

  • OTHER INFORMATION

    • each tablet contains: calcium 140 mg/table
    • store at room temperature, USP
    • protect from moisture
    • do not use if imprinted safety seal under cap is broken or missing

  • INACTIVE INGREDIENT

    caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

  • QUESTIONS OR COMMENTS?

    1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark FiberCon®

    Distributed by: MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL

    NDC 0904-2500-91

    MAJOR

    Fiber-Tabs TM

    Bulk-Forming Laxative

    Calcium Polycarbophil 625 mg

    Fiber Therapy for Regularity

    *Compare to the active ingredient in FiberCon®

    90 Tablets

    0339-major-label

  • INGREDIENTS AND APPEARANCE
    FIBER TABS 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2500
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARAMEL (UNII: T9D99G2B1R)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (Off white) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code CPC;339
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-2500-9190 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/2010
    Labeler - Major Pharmaceuticals (191427277)