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KONSYL Daily Therapy Fiber (Konsyl Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 90 TABLET in 1 BOTTLE (0224-0500-90) Label Information

Complete KONSYL Daily Therapy Fiber Information

  • KONSYL Daily Therapy Fiber Caplets


  • Active Ingredient (in each caplet)

    Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil


  • Purpose

    Laxative


  • Uses

    relieves:

    • constipation
    • helps restore and maintain regularity
    • promotes normal function of the bowel
    • 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.

    This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.


  • DO NOT USE

    Do not use if you are taking any form of tetracycline antibiotic.


  • 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 DOCTOR/PHARMACIST

    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 drug 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 bowel movement after use
    • rectal bleeding occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.


  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center immediately.


  • Directions

    • Take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid.  Taking this product without enough liquid may 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 years
    2 caplets, 1 to 4 times a day
    children 6 to under 12 years
    1 caplet, once a day
    children under 6 years
    ask a doctor

  • Other information

    • each caplet contains: calcium 135 mg
    • do not use if printed seal under cap is torn or missing
    • store at room temperature
    • protect contents from moisture

  • Inactive ingredients

    calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.


  • TO REPORT ADVERSE DRUG EVENTS CALL: 800-356-6795



  • Package Labeling

    LabelLabel2


  • INGREDIENTS AND APPEARANCE
    KONSYL DAILY THERAPY FIBER 
    calcium polycarbophil tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-0500
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARAMEL (UNII: T9D99G2B1R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Color white (Very Light Beige, Speckled) Score no score
    Shape BULLET Size 19mm
    Flavor Imprint Code G147
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0224-0500-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2012
    2 NDC:0224-0500-80 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/12/2012
    Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
    Registrant - Konsyl Pharmaceuticals, Inc. (102463866)
    Establishment
    Name Address ID/FEI Business Operations
    Konsyl Pharmaceuticals, Inc. 102463866 manufacture(0224-0500)