Label: CALCIUM POLYCARBOPHIL tablet, film coated

  • NDC Code(s): 58624-5003-1
  • Packager: SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
  • 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 April 24, 2023

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  • Drug Facts

    Active ingredient (in each caplet)

    Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

  • Purpose

    Bulk-forming laxative

  • Uses

    relieves occasional constipation (irregularity)

    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 two or more hours before or after other drugs. 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

    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 right away.

  • Directions

    take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my 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 over 12 years2 caplets, 1 to 4 times per day
    children under 12 yearsask a doctor

  • Other information

    each caplet contains: calcium 140 mg

    do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
    protect contents from moisture

  • INACTIVE INGREDIENT

    Caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

  • Questions or comments?

    Call 1-844-374-0016 weekdays 9 AM to 5 PM EST

  • PRINCIPAL DISPLAY PANEL

    Fiber Caplets

    Compare to the active ingredient in FiberCon ®

    BULK-FORMING / FIBER LAXATIVE

    • GENTLE RELIEF OF CONSTIPATION
    • WON’T CAUSE GAS OR BLOATING
    • EFFECTIVE AS FIBER POWDERS

    Manufactured and Distributed by: Shandong Xinhua Pharmaceutical Co., Ltd. Zibo, Shandong 255086, P.R. China

    90 Caplets

    updated label

  • INGREDIENTS AND APPEARANCE
    CALCIUM POLYCARBOPHIL 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58624-5003
    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
    CARAMEL (UNII: T9D99G2B1R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorwhite (off white) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code XH;C1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58624-5003-190 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/12/2023
    Labeler - SHANDONG XINHUA PHARMACEUTICAL CO., LTD. (653915728)
    Registrant - SHANDONG XINHUA PHARMACEUTICAL CO., LTD. (554507599)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Xinhua Pharmaceutical Co., Ltd.554507599manufacture(58624-5003)
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