VITAMIN D3 1.25 MG 50000 IU Dietary Supplement: Package Insert and Label Information

VITAMIN D3 1.25 MG 50000 IU DIETARY SUPPLEMENT- cholecalciferol and .alpha.-tocopherol, d- capsule, gelatin coated
Nnodum Pharmaceuticals

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 SUPPLIE D
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
(click image for full-size original)

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VITAMIN D3 1.25 MG 50000 IU DIETARY SUPPLEMENT cholecalciferol capsule, gelatin coated
Product Information
Product Type Item Code (Source) NDC:63044-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1.25 mg
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 10 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
GLYCERIN
GELATIN TYPE B BOVINE (230 BLOOM)
WATER
Product Characteristics
Color white Score no score
Shape CAPSULE (Softgel) Size 5mm
Flavor Imprint Code N402
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63044-402-01 30 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 05/27/2021
Labeler — Nnodum Pharmaceuticals (960457273)
Registrant — Nnodum Pharmaceuticals (960457273)

Revised: 05/2021 Nnodum Pharmaceuticals

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