Cobalefol

Cobalefol
SPL v1
SPL
SPL Set ID 7d409065-112d-4bc7-bae6-d558aeb7c0e4
Route
ORAL
Published
Effective Date 2025-05-16
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ascorbic Acid (90 mg) Cholecalciferol (20 ug) .alpha.-tocopherol, D- (10.5 mg) Flavin Mononucleotide (1.4 mg) Niacinamide (1.6 mg) Pyridoxine (16.3 mg) Folic Acid (2.5 mg) Methylcobalamin (1700 ug)
Inactive Ingredients
Microcrystalline Cellulose Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-05-16

Description

Cobalefol Capsules - Vitamins dispensed by prescription Supplement Facts Serving Size: 1 Capsule Servings Per Bottle: 30  Ingredients  Amount Per Serving %DV  Vitamin C (as Ascorbic Acid)  90 mg  100%  Vitamin D3 (as Cholecalciferol)  20 mcg  100%  Vitamin E (as d-Alpha Tocopheryl Succinate)  10.05 mg  67%  Thiamine (as Thiamine Mononitrate)  1.4 mg  116%  Riboflavin (as Riboflavin 5 Phosphate)  1.6 mg  123%  Niacin (as Niacinamide)  16.3 mg  101%  Vitamin B-6 (as Pyridoxine HCl)  2.5 mg  147%  Folate (from 1000 mcg Folic Acid)  1700 mcg DFE  425%  Vitamin B-12 (as Methylcobalamin)  10 mcg  416% Other ingredients : Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

Contraindications

Cobalefol is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

Storage and Handling

Store at room temperature. Avoid excessive heat, light, and moisture. 

How Supplied

Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01 Manufactured for: V2 Pharma, LLC 103 W Main Street Hudson, MI 49247


Medication Information

Contraindications

Cobalefol is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

Storage and Handling

Store at room temperature. Avoid excessive heat, light, and moisture. 

How Supplied

Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01

Manufactured for:

V2 Pharma, LLC

103 W Main Street

Hudson, MI 49247

Description

Cobalefol Capsules - Vitamins dispensed by prescription Supplement Facts Serving Size: 1 Capsule Servings Per Bottle: 30  Ingredients  Amount Per Serving %DV  Vitamin C (as Ascorbic Acid)  90 mg  100%  Vitamin D3 (as Cholecalciferol)  20 mcg  100%  Vitamin E (as d-Alpha Tocopheryl Succinate)  10.05 mg  67%  Thiamine (as Thiamine Mononitrate)  1.4 mg  116%  Riboflavin (as Riboflavin 5 Phosphate)  1.6 mg  123%  Niacin (as Niacinamide)  16.3 mg  101%  Vitamin B-6 (as Pyridoxine HCl)  2.5 mg  147%  Folate (from 1000 mcg Folic Acid)  1700 mcg DFE  425%  Vitamin B-12 (as Methylcobalamin)  10 mcg  416% Other ingredients : Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

Warnings

KEEP COBALEFOL OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.

For use under the supervision of a licensed medical practitioner.

Consult your physician prior to using Cobalefol if you are pregnant, nursing, taking medication, or have a medical condition. 

Precaution

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Cobalefol should only be used under the direction and supervision of a licensed medical practitioner.

Statements

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.

Description:

Cobalefol is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Cobalefol provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet.

Cobalefol Label

Supplement Facts

Cobalefol Capsules - Vitamins dispensed by prescription

Supplement Facts

Serving Size: 1 Capsule

Servings Per Bottle: 30

 Ingredients  Amount Per Serving %DV
 Vitamin C (as Ascorbic Acid)  90 mg  100%
 Vitamin D3 (as Cholecalciferol)  20 mcg  100%
 Vitamin E (as d-Alpha Tocopheryl Succinate)  10.05 mg  67%
 Thiamine (as Thiamine Mononitrate)  1.4 mg  116%
 Riboflavin (as Riboflavin 5 Phosphate)  1.6 mg  123%
 Niacin (as Niacinamide)  16.3 mg  101%
 Vitamin B-6 (as Pyridoxine HCl)  2.5 mg  147%
 Folate (from 1000 mcg Folic Acid)  1700 mcg DFE  425%
 Vitamin B-12 (as Methylcobalamin)  10 mcg  416%

Other ingredients: Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

Doseage and Administration

Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner. 


Structured Label Content

Warnings (WARNINGS)

KEEP COBALEFOL OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.

For use under the supervision of a licensed medical practitioner.

Consult your physician prior to using Cobalefol if you are pregnant, nursing, taking medication, or have a medical condition. 

Precaution

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Cobalefol should only be used under the direction and supervision of a licensed medical practitioner.

Statements

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.

Description:

Cobalefol is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Cobalefol provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet.

How Supplied

Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01

Manufactured for:

V2 Pharma, LLC

103 W Main Street

Hudson, MI 49247

Cobalefol Label

Supplement Facts

Cobalefol Capsules - Vitamins dispensed by prescription

Supplement Facts

Serving Size: 1 Capsule

Servings Per Bottle: 30

 Ingredients  Amount Per Serving %DV
 Vitamin C (as Ascorbic Acid)  90 mg  100%
 Vitamin D3 (as Cholecalciferol)  20 mcg  100%
 Vitamin E (as d-Alpha Tocopheryl Succinate)  10.05 mg  67%
 Thiamine (as Thiamine Mononitrate)  1.4 mg  116%
 Riboflavin (as Riboflavin 5 Phosphate)  1.6 mg  123%
 Niacin (as Niacinamide)  16.3 mg  101%
 Vitamin B-6 (as Pyridoxine HCl)  2.5 mg  147%
 Folate (from 1000 mcg Folic Acid)  1700 mcg DFE  425%
 Vitamin B-12 (as Methylcobalamin)  10 mcg  416%

Other ingredients: Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

Contraindications

Cobalefol is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

Storage and Handling

Store at room temperature. Avoid excessive heat, light, and moisture. 

Doseage and Administration

Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner. 


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