GOOD SENSE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [L. PERRIGO COMPANY]

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GOOD SENSE FIBER LAXATIVE (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [L. PERRIGO COMPANY]
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NDC 0113-0477-75, 0113-0477-92
Set ID 90b3332b-1ab4-4af8-a1c1-21395d0186ab
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient (in each caplet)

    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
    •
    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 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. (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 and 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 140 mg and magnesium 10 mg
    •
    store at 20-25oC (68-77oF)
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Easy To Take

    Bulk-Forming Laxative

    Calcium Polycarbophil 625 mg

    Fiber Laxative

    Fiber Therapy for Regularity

    Gentle Enough for Everyday Use

    As Effective as Fiber Powders

    Won’t Ferment to Cause Gas or Bloating

    Compare to active ingredient of FiberCon®

    Fiber Laxative Label Image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE FIBER LAXATIVE 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0477
    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)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorBROWN (light) Score2 pieces
    ShapeCAPSULE (caplet) Size19mm
    FlavorImprint Code L477
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0477-7590 in 1 BOTTLE; Type 0: Not a Combination Product08/01/199703/26/2019
    2NDC:0113-0477-92140 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/1997
    Labeler - L. Perrigo Company (006013346)
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