KONSYL ORIGINAL FORMULA PSYLLIUM FIBER (PSYLLIUM HUSK) GRANULE [KONSYL PHARMACEUTICALS, INC.]

KONSYL ORIGINAL FORMULA PSYLLIUM FIBER (PSYLLIUM HUSK) GRANULE [KONSYL PHARMACEUTICALS, INC.]
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NDC 0224-1801-06, 0224-1801-07, 0224-1801-35, 0224-1801-80, 0224-1801-81, 0224-1801-84
Set ID 6c876cf1-c2ab-4bdc-bb3e-ac2ce5863649
Category HUMAN OTC DRUG LABEL
Packager Konsyl Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART334
  • Konsyl Original Formula Psyllium Fiber

  • Active Ingredients (in each teaspoon)

    Psyllium Hydrophilic Mucilloid 6g

    Purpose

    Laxative

  • Uses

    For relief of occasional constipation and to induce regularity.

    This product generally produces bowel movements 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 6g dose contains: Potassium 50mg
    • laxatives, including bulk fibers, may affect how other 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

    none

  • Questions or comments?

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

    Label 2

  • Package Labeling: 0224-1801-80

    Label 01

  • Package Labeling: 0224-1801-84

    Label 02

  • Package Labeling: 0224-1801-88

    Label 03

  • INGREDIENTS AND APPEARANCE
    KONSYL ORIGINAL FORMULA PSYLLIUM FIBER 
    psyllium husk granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK6 g  in 6 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0224-1801-8430 in 1 BOX03/31/2011
    16 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0224-1801-3530 in 1 BOX03/31/201103/01/2020
    26 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0224-1801-07450 g in 1 CANISTER; Type 0: Not a Combination Product03/31/201104/01/2020
    4NDC:0224-1801-81450 g in 1 CANISTER; Type 0: Not a Combination Product03/31/2011
    5NDC:0224-1801-06300 g in 1 CANISTER; Type 0: Not a Combination Product03/31/201104/01/2020
    6NDC:0224-1801-80300 g in 1 CANISTER; Type 0: Not a Combination Product03/31/2011
    7NDC:0224-1801-88402 g in 1 BOTTLE; Type 0: Not a Combination Product10/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/31/2011
    Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
    Registrant - Konsyl Pharmaceuticals, Inc. (102463866)