ENL : Package Insert / Prescribing Info

ENL Description

ENLTM is a medical food for use under medical supervision to assist patients with MTHFR polymorphisms and other B-vitamin polymorphisms or “IEMs” in the clinical dietary management of depression and is specially formulated to meet the distinctive nutritional requirements for these patients.

Each ENLTM capsule contains 15 mg DFE of reduced folates (from 7mg LevoMeFolic Acid [L-methylfolate Magnesium, CAS# 1429498-11-2] and ~3.5mg Levoleucovorin [folinic acid]) plus adenosylcobalamin.

A recent study+ suggested that EnLyte® was effective in lowering homocysteine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism).

+ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism.

INGREDIENTS: Olive oil, gelatin, magnesium ascorbate, Sharp-PS® Gold (phosphatidylserine-DHA complex), yellow beeswax, purified water, sodium citrate, l-methylfolate magnesium, sunflower lecithin, folinic acid, citric acid, annatto extract, elemental iron1 (from ferrous glycine cysteinate), zinc ascorbate, magnesium l-threonate, natural orange flavor, piperine, CoQ10 (ubidecarenone), betaine, vitamin B12 (adenosylcobalamin), FAD (flavin adenine dinucleotide), NADH (nicotinamide adenosine dinucleotide hydride), vitamin B6 (pyridoxal 5’ phosphate), vitamin B1 (thiamine pyrophosphate).

1 Pure amino acid, cysteinated iron chelate as AminoFerr® under exclusive license by Viva Pharmaceuticals, Canada, U.S. Patent #7341708.

CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.

Indications and Usage for ENL

Clinical dietary management of major depressive disorder.

Adverse Reactions/Side Effects

Allergic reactions have been reported following the use of oral folate. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with Vitamin B12.

Precautions

Folinic acid, when administered in daily doses above 0.1 mg, may obscure the detection of B12 deficiency specifically, the administration of folinic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological issues. Folate therapy alone is inadequate for the treatment of a B12 deficiency.

ENL Dosage and Administration

The usual dose is one (1) ENL capsule given daily with or without food, or as directed under medical supervision. No age restrictions.

You may report side effects by calling 337.662-5962.

KEEP THIS OUT OF THE REACH OF CHILDREN.

Do not exceed the recommended dose.

How is ENL supplied

ENL Bottle of 30 Product Code # 64661-082-25*. Each ENL reddish brown oval softgel is imprinted with “082”.

*JAYMAC does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems.

Storage and Handling

Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from heat, light and moisture.

(Tamper Evident: Do not use if seal is broken or missing.)

JAYMAC Pharmaceuticals, LLC, 2085 I-49 S. Service Rd, Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/CANADA

​Rev April 10, 2024 (V17)

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