Levomefolate Calcium Algal Capsules

Generic name: levomefolate calcium and schizochytrium dha oil
Dosage form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Levomefolate Calcium/ Algal Powder Capsules

(15 mg-90.314 mg)

DIETARY MANAGEMENT / PRESCRIPTION (Rx) FOLATE

58657-208-90 (90 Capsules)

Certified Gluten Free

Rx

DESCRIPTION:

Levomefolate Calcium/ Algal Powder Capsules (15 mg-90.314 mg) are an orally administered prescription folate-containing product specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. This product should be administered under the supervision of a licensed medical practitioner.

Each capsule contains: 15 mg of L-Methylfolate Calcium*, 90.314 mg of Algal Powder (Schizochytrium).

*CAS#151533-22-1

INGREDIENTS: Each opaque orange cap and opaque white body capsule contains the following ingredients:

L-Methylfolate Calcium* 15 mg

Algal Powder (Schizochytrium) 90.314 mg

* CAS#151533-22-1

Other Ingredients May Contain: Microcrystalline Cellulose, Gelatin, Glutathione, Ascorbic Acid, Vegetable Magnesium Stearate, Silica, Titanium Dioxide (color), Modified Starch, Sugar, Maltodextrin, Tocopherol, Corn Oil, Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, FD&C Yellow #6, Red #40, and Water.

CAUTION: Contains soy. This product also contains bovine gelatin, FD&C Yellow #6, and Red #40.

INDICATIONS AND USAGE:

Levomefolate Calcium/ Algal Powder Capsules (15 mg-90.314 mg) are indicated for the distinct nutritional requirements of patients in need of advanced folate supplementation, specifically suboptimal L-methylfolate or maintenance-level needs, as determined by a licensed medical practitioner.

DOSAGE AND ADMINISTRATION:

The usual adult dose is one capsule daily with or without food or as directed by a licensed medical practitioner.

FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocyst...