Label: ENZADYNE- proamylipase capsule

  • NHRIC Code(s): 69336-403-30
  • Packager: Sterling Knight Pharmaceuticals LLC
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated June 18, 2019

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  • HEALTH CLAIM:

    Enzadyne Capsules Dietary Supplemement

    Dispensed by Prescription†

  • DESCRIPTION:

    Enzadyne is an orally administered prescription digestive enzyme formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

    Enzadyne should be administered under the supervision of a licensed medical practitioner.

    INDICATIONS AND USAGE:
    Enzadyne is an orally administered prescription digestive enzyme formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

  • WARNINGS AND PRECAUTIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

    Enzadyne should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

  • DOSAGE AND ADMINISTRATION:

    Usual adult dose is 1 capsule daily with or without food. Do not exceed 3 capsules per day.

  • STORAGE:

    Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

  • PACKAGE LABEL:

    labelenza

    Reserved for Professional Recommendation

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

    Manufactured for:

    Sterling-Knight Pharmaceuticals, LLC

    Ripley, MS 38663

  • INGREDIENTS AND APPEARANCE
    ENZADYNE 
    proamylipase capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69336-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E) PANCRELIPASE AMYLASE112500 [USP'U]
    PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50) PANCRELIPASE PROTEASE112500 [USP'U]
    PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE9000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69336-403-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/05/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)22 mm
    scoring1
    Labeler - Sterling Knight Pharmaceuticals LLC (079556942)