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KONSYL 100 Percent Natural Psyllium Fiber (Konsyl Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
CAPSULE 1 BOTTLE in 1 BOX (0224-1847-10) > 100 CAPSULE in 1 BOTTLE Label Information

Complete KONSYL 100 Percent Natural Psyllium Fiber Information

  • KONSYL 100% Natural Psyllium Fiber Capsules


  • Active ingredient (in each capsule)

    Psyllium husk approx. 20 mg


  • Purpose

    Laxative


  • Uses

    • for relief of occasional constipation  and to induce regularity. This product generally produces bowel movement  within 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.


  • Do not use

    • when abdominal pain, nausea or vomiting are present unless directed by a doctor
    • If constipation lasts more than seven days
    • if you have difficulty swallowing

  • Ask a doctor before use if you have

    • noticed a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you experience rectal bleeding or fail to have a bowel movement, as these may 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



    adults and children 12 years and over
    5 capsules one to three times daily
    children under 12 years
    consult a doctor

    • Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
    • follow dosage above or use as directed by a doctor

  • Other information

    • laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines
    • tamper-evident bottle mouth sealed for your protection
    • do not use if imprinted inner seal is broken or missing
    • store below 86  degrees F (30 degrees C)
    • can be taken before or after meals, mornings or evenings

  • Inactive ingredients

    FDandC yellow 6, gelatin. polyethylene glycol, polysorbate 80


  • Representative Labeling

    Label


  • INGREDIENTS AND APPEARANCE
    KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER  
    psyllium husk capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1847
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color white (CLEAR) Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code P620
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0224-1847-80 1 in 1 BOX 03/31/2011
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0224-1847-10 1 in 1 BOX 03/31/2011
    2 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/31/2011
    Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
    Establishment
    Name Address ID/FEI Business Operations
    Konsyl Pharmaceuticals, Inc. 102463866 manufacture(0224-1847)