Label: ZYVANA capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 22, 2021

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  • DESCRIPTION

    Zyvana is an orally administered prescription dietary supplement formulation.

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

    supplement

    Other Ingredients: Soybean Oil, Gelatin (bovine), Garlic Powder, Glycerin, Lecithin, Beeswax, Purified Water, Titanium Dioxide, FD&C Yellow #5.

  • INDICATIONS AND USAGE

    Zyvana is an orally administered prescription dietary supplement formulation for the 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.Zyvana 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

    The usual dose of Zyvana is 2 capsules per day.The daily dose may be taken as a single dose of 2 capsules or 1 capsule twice daily.

  • HOW SUPPLIED SECTION

    Zyvana is supplied as yellow softgel capsule printed with 405 dispensed in white HDPE plastic bottles of 60ct. 69336-405-60

  • 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.

  • Reserved for Professional Recommendation

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Manufactured for:

    Sterling-Knight Pharmaceuticals, LLC

    Ripley, MS 38663 

    Item 40560

    Rev. 0920-1

    label

  • INGREDIENTS AND APPEARANCE
    ZYVANA 
    zyvana capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-405
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID527 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.041 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12 mg
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE23 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM0.097 mg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    GELATIN (UNII: 2G86QN327L)  
    GARLIC (UNII: V1V998DC17)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEG-8 BEESWAX (UNII: 3C1QUF1TIR)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Coloryellow (softgel capsule) Score4 pieces
    ShapecapsuleSize14mm
    FlavorImprint Code 405
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69336-405-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/22/2021
    Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
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