Label: CALCIUM POLYCARBOPHIL 625 MG 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 October 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Calcium polycarbophil 625 mg

    (equivalent to polycarbophil 500 mg)

  • Purpose

    Bulk-Forming Laxative

  • Uses

    • relieves occasional constipation
    • 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 cuase 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.

  • DO NOT USE

    Do not use longer than one week

  • ASK DOCTOR

    Ask a doctor before use if you have

    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that lasts over two weeks
  • ASK DOCTOR/PHARMACIST

    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.

  • STOP USE

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after using this prodcut

    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Drug Facts continued on back of label

  • Directions

    • take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
    • take dose up to 4 times daily
    • do not take more than 8 caplets in 24 hours
    • adults & children 12 years and over: 2 caplets
    • children under 12 years: ask a doctor
  • Other information

    • each caplet contains: calcium 140 mg
    • store at 15°-30°C (59°-86°F)
    • do not refrigerate
    • protect from humidity
  • INACTIVE INGREDIENT

    Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

  • QUESTIONS

    Questions or comments? call 516-341-0666,

    8:30 am - 4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark FIBERCON®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliablel1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-030-06

    Calcium Polycarbophil 625mg

    Bulk-Forming Laxative

    90 Caplets

    *Compare to Active Ingredient in FIBERCON®

    Calcium Polycarbophil 625 mg

  • INGREDIENTS AND APPEARANCE
    CALCIUM POLYCARBOPHIL 625 MG 
    calcium polycarbophil 625 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-030
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CAROB (UNII: 5MG5Z946UO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code AP;067
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-030-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    2NDC:69618-030-0990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    3NDC:69618-030-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
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