Label: VITAMIN D3 1.25 MG 50000 IU DIETARY SUPPLEMENT- cholecalciferol capsule, gelatin coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated May 27, 2021

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  • Statement of Identity

    VITAMIN D3 1.25MG (50,000IU) Softgel Capsule


    CHOLECALCIFEROL, USP (50,000IU)
    Vitamin E- D-alpha Tocopherol 10mg (1000IU)

  • Warnings

    WARNINGS: Vitamin D3 is a high Potency dietary supplement. Do not exceed recommended dosage. Not recommended for children, pregnant or lactating women, or individuals with liver disease, and those taking thiazide diuretics may be at greater risk of toxicity.

  • Dosage & Administration

    DIRECTIONS: Take 0ne (1) capsule each week, or as directed by your physician.

    Take with food. Store in cool dry place. Protect from light.

  • Precautions/Warning

    These statements have not been evaluated by the Food and Drug Administration.

    This product is not intended to diagnose, treat, cure or prevent any disease.

  • Storage

    Store in cool dry place. Protect from light.

  • Health Claims

    DIETARY SUPPLEMENT

    Vitamin D3 50,000 IU is essential for absorption of calcium and necessary for healthy bones and a healthy immune system.

  • Vitamin D3 Product Label

    NDC 63044-402-01
    VITAMIN D3 1.25MG (50,000IU) Softgel Capsule
    CHOLECALCIFEROL, USP (50,000IU)
    Vitamin E- D-alpha Tocopherol 10mg (1000IU)

    DIETARY SUPPLEMENT

    Vitamin D3 50,000 IU is essential for absorption of calcium and necessary for healthy bones and a healthy immune system.

    WARNINGS: Vitamin D3 is a high Potency dietary supplement. Do not exceed recommended dosage. Not recommended for children, pregnant or lactating women, or individuals with liver disease, and those taking thiazide diuretics may be at greater risk of toxicity.

    DESCRIPTION
    Vitamin D3 (Cholecalciferol) is a clear gelatin softgel capsule marked “N402”. Vitamin D3 is a fat-soluble high potency vitamin that helps your body absorb calcium and phosphorus. Cholecalciferol is a softgel capsule, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. One Unit of vitamin D3 is equivalent to one International Unit (IU). Each softgel capsule, for oral administration, contains Cholecalciferol, 1.25 mg (equivalent to 50,000 USP units of Vitamin D).

    Other Ingredients: Soybean oil, Glycerin, Bovine Gelatin and Purified water.

    DIRECTIONS: Take 0ne (1) capsule each week, or as directed by your physician. Take with food.

    Store in cool dry place. Protect from light.

    INDICATIONS AND USAGE
    Cholecalciferol Softgel capsule is essential for absorption of calcium and necessary for healthy and strong bones. .

    CONTRAINDICATIONS
    Cholecalciferol softgel capsules are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
    Keep out of the reach of children.

    DIRECTIONS: Take 0ne (1) capsule each week, or as directed by your physician. Take with food. Store in cool dry place. Protect from light.

    Supplement Facts *
    Serving Size: One Softgel Capsule
    Each softgel capsule Contains: Vitamin D31.25mg (Cholecalciferol) 50,000 IU and Vitamin E- D-alpha Tocopherol 10mg (1000IU)

    HOW SUPPLIED
    Bottle of 30 softgel capsule (NDC 63044-402-01).

    Store at 20°– 25°C (68°–77°F) [See USP Controlled Room Temperature].
    Protect from light and moisture.
    Dispense in a tight, light-resistant container as defined in the USP.

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

    Manufactured For:
    Nnodum Pharmaceuticals Corp.
    Cincinnati, Ohio 45240
    United States of America
    www.nnodumpharma.com

    Nnodum Vitamin D3 Label

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  • INGREDIENTS AND APPEARANCE
    VITAMIN D3 1.25 MG 50000 IU  DIETARY SUPPLEMENT
    cholecalciferol capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:63044-402
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1.25 mg
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:63044-402-0130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT05/27/2021
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    imprint
    size (solid drugs)5 mm
    Labeler - Nnodum Pharmaceuticals (960457273)
    Registrant - Nnodum Pharmaceuticals (960457273)