COBALEFOL- vitamin capsule

Cobalefol by

Drug Labeling and Warnings

Cobalefol by is a Prescription medication manufactured, distributed, or labeled by V2 Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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.

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.

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.

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. 

Doseage and Administration

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

Storage and Handling

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

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.

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

INGREDIENTS AND APPEARANCE

COBALEFOL 
vitamin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72835-550
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	90 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	10.5 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	1.4 mg
RIBOFLAVIN 5'-PHOSPHATE (UNII: 7N464URE7E) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E)	RIBOFLAVIN 5'-PHOSPHATE	1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	16.3 mg
PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	2.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1700 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	10 ug

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	16mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72835-550-01	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/16/2025

Labeler - V2 Pharma LLC (102457346)

Establishment
Name	Address	ID/FEI	Business Operations
V2 Pharma LLC		102457346	label(72835-550) , manufacture(72835-550)