Label: FIBER CAPLETS- 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 January 29, 2020

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

  • Drug Fats

    Active Ingredient (in each caplet)

    Calcium polycarbophil 625 mg

    equivalent to 500 mg polycarbophil

  • PURPOSE

    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 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 your 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 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 at 1-800-222-1222.

  • 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).
    this product 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.

    Age

    Recommended dose

    Daily maximum

    adults & children 12 years of age and over

    2 caplets once a day

    up to 4 times a day

    children under 12 years

    consult a physician

  • Other information

    each caplet contains: calcium 125 mg
    store at room temperature
    protect contents from moisture

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • INACTIVE INGREDIENT

    calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

  • Questions or Comments?

    1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    NDC# 30142-132-14

    *COMPARE TO the active ingredients of FIBERCON® CAPLETS

    *See side panel

    Fiber Caplets

    Calcium Polycarbophil 625 mg

    Bulk-Forming

    Fiber Laxative

    Gentle Relief of Constipation
    Won’t Cause Gas or Bloating
    As effective as Fiber Powders

    140 CAPLETS

    DIST. BY: THE KROGER CO.

    CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    800-632-6900

    www.kroger.com

    *Fibercon® is a registered trademark of Pfizer Inc., New York, NY 10017. Pfizer Inc., is not affiliated with The Kroger Co. or this product.

    Kroger Fiber Caplets Calcium Polycarbophil 140 counts
  • INGREDIENTS AND APPEARANCE
    FIBER CAPLETS 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-132
    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)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorBROWN (light) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code RP120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-132-14140 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/26/2019
    Labeler - THE KROGER CO. (006999528)