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KONSYL Sugar Free Orange Flavor Psyllium Fiber (Konsyl Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
GRANULE 450 g in 1 CANISTER (0224-1855-07) Label Information
GRANULE 30 PACKET in 1 BOX (0224-1855-30) > 5.8 g in 1 PACKET Label Information
GRANULE 300 g in 1 CANISTER (0224-1855-06) Label Information

Complete KONSYL Sugar Free Orange Flavor Psyllium Fiber Information

  • KONSYL Sugar Free Orange Flavor Psyllium Fiber


  • Active Ingredient (in each teaspoon)


    Psyllium Hydrophilic Mucilloid 3.5 g


  • Purpose

    • Laxative

  • Uses

    For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within  12-72 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

    Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.

    adults and children 12 years and older
    one teaspoon 1 to 3 times daily
    children 6 to under 12 years of age
    1/2 teaspoon 1 to 3 times daily
    children under 6 years of age
    consult a doctor.

  • Other information

    • each 5.8g dose contains Potassium 25mg
    • Phenylketonurics: Contains phenylalanine, 21 mg per teaspoon
    • 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
    • do not discard Konsyl into any plumbing system
    • store below 86  degrees F (30 degrees C)
    • keep container tightly closed-protect from excessive moisture
    • can be taken before or after meals, mornings or evenings

  • Inactive Ingredients

    Aspartame, Citric Acid, FD and C Yellow No. 6, Maltodextrin, Natural and Artificial Orange Flavor, Silicon dioxide.


  • Questions or Comments?

    1-800-356-6795 8:30 a.m. to 5 p.m. ET.


  • Representative Labeling

    Label


  • INGREDIENTS AND APPEARANCE
    KONSYL SUGAR FREE ORANGE FLAVOR PSYLLIUM FIBER  
    psyllium husk granule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1855
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.5 g  in 5.8 g
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0224-1855-30 30 in 1 BOX 03/31/2011
    1 5.8 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0224-1855-82 30 in 1 BOX 03/31/2011
    2 5.8 g in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0224-1855-06 300 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011
    4 NDC:0224-1855-07 450 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011
    5 NDC:0224-1855-81 450 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011
    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(0224-1855)