VITAMIN D3 1.25 MG 50000 IU

Manufacturer
Nnodum Pharmaceuticals
Effective date
2021-05-27
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:00

Label at a glance#

ProductVITAMIN D3 1.25 MG 50000 IU Dietary Supplement
Active ingredientCHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-
Label structure7 sections

Label contents#

Full prescribing information#

Statement of Identity

STATEMENT OF IDENTITY SECTION

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


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

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

PRECAUTIONS SECTION

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

SAFE HANDLING WARNING SECTION

Store in cool dry place. Protect from light.

Health Claims

HEALTH CLAIM SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelNnodum Vitamin D3 Label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2566811alpha tocopherol 10 MG / cholecalciferol 1.25 MG Oral CapsulePSN1
2566811alpha tocopherol 10 MG / cholecalciferol 1.25 MG Oral CapsuleSCD1
2566811cholecalciferol 50,000 UNT / vitamin E 10,000 UNT Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63044-402-01VITAMIN D3 1.25 MG 50000 IUDietary Supplement30 in 1 BOTTLECAPSULE, GELATIN COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63044-402VITAMIN D3 1.25 MG 50000 IU DIETARY SUPPLEMENT (CHOLECALCIFEROL) CAPSULE, GELATIN COATED [NNODUM PHARMACEUTICALS]11 package rows20210529_744f7be5-5bfb-4f18-a11c-0d77ae7a2174.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-402-01EA - Each63044-4027705c7c8-64ee-44ed-b8d7-501e645a031712021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63044-40263044-402-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.