Cobalefol Capsule
FDA Label NDC 72835-550

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by V2 Pharma Llc for the product Cobalefol (NDC 72835-550). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding supplement facts, description:, contraindications, precaution, warnings, doseage and administration, storage and handling, statements, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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