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  5. Label Information: Cobalefol

FDA Label for Cobalefol

View Indications, Usage & Precautions

Table of Contents

    1. SUPPLEMENT FACTS
    2. DESCRIPTION:
    3. CONTRAINDICATIONS
    4. PRECAUTION
    5. WARNINGS
    6. DOSEAGE AND ADMINISTRATION
    7. STORAGE AND HANDLING
    8. STATEMENTS
    9. HOW SUPPLIED
    10. COBALEFOL LABEL

Cobalefol Product Label

The following document was submitted to the FDA by the labeler of this product V2 Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.