Label: NICAZYME- nicazyme tablet

  • NDC Code(s): 69336-404-30
  • Packager: Sterling Knight Pharmaceuticals LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated June 18, 2019

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

  • DESCRIPTION:

    Nicazyme is an orally administered prescription dietary supplement 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.


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

    INDICATIONS AND USAGE:

    Nicazyme is indicated for patients who are deficient in, or at risk of deficiency, in, one or more of the components of the product.

    Close
  • CONTRAINDICATIONS:

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

    Close
  • WARNINGS AND PRECAUTIONS:

    This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus.

    Folic acid above 1mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

    Abnormal liver function test have reported in persons takings doses of 500mg or more of naicinamide.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Close
  • ADVERSE REACTION:

    Allergic sensitization has been reported following both oral and parental administration of folic acid.

    Close
  • DOSAGE AND ADMINISTRATION:

    Usual dose is 1 to 2 tablets daily with or without food. Do not exceed 3 tablets per day.

    Close
  • 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.

    HOW SUPPLIED:

    Nicazyme is supplied a beige tablet dispensed in white HDPE plastic bottles of 30ct.

    Close
  • PRINCIPAL DISPLAY PANEL

    IMAGEBOX

    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

    Close
  • INGREDIENTS AND APPEARANCE
    NICAZYME 
    nicazyme tablet
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69336-404
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 250 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 0.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 4.5 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 1.4 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 9 mg
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:69336-404-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 06/05/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    size (solid drugs) 22 mm
    scoring 1
    Labeler - Sterling Knight Pharmaceuticals LLC (079556942)
    Close