Label: KONSYL SUGAR FREE ORANGE WITH STEVIA- psyllium husk powder

  • NDC Code(s): 0224-1884-81, 0224-1884-82
  • Packager: Konsyl Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 2, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient (in each teaspoon)

    Psyllium Hydrophilic Mucilloid 3.5g

    Purpose

    Laxative

  • Use

    For relief of occasional constipation and aid in 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 of 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 35mg
    • 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 use discard konsyl inot any plumbing system
    • store below 86° F (30° C)
    • keep container tightly closed-protect from excessive moisture
    • can be taken before or after meals, mornings or eveings
  • Inactive Ingredients

    Citric Acid, FD&C Yellow No.6, Maltodextrin, Natural and Artificial Orange Flavor, Rebaudioside A, Silicon Dioxide.

  • Questions or Comments?

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

  • Konsyl Sugar free Orange With Stevia, 450g (0224-1884-81)

    Label2

  • Package Labeling: 0224-1884-82

    Label 08

  • INGREDIENTS AND APPEARANCE
    KONSYL SUGAR FREE ORANGE WITH STEVIA 
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1884
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.5 g  in 5.8 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0224-1884-8177 in 1 CARTON10/01/2018
    15.8 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:0224-1884-8230 in 1 CARTON10/01/2018
    25.8 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2018
    Labeler - Konsyl Pharmaceuticals, Inc. (102463866)