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

VITAMIN D3 1.25 MG 50000 IU by

Drug Labeling and Warnings

VITAMIN D3 1.25 MG 50000 IU by is a Other medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:63044-402
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1.25 mg
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	10 mg

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63044-402-01	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		05/27/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
imprint
size (solid drugs)	5 mm

Labeler - Nnodum Pharmaceuticals (960457273)

Registrant - Nnodum Pharmaceuticals (960457273)