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EnLyte (leucovorin 2.5 mg folic acid 1 mg levomefolate magnesium 7 mg ferrous cysteine glycinate 13.6 mg 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium 6.4 mg 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium 800 ug phosphatidyl serine 12 mg pyridoxal phosphate anhydrous 25 ug flavin adenine dinucleotide 25 ug nadh 25 ug cobamamide 50 ug cocarboxylase 25 ug magnesium ascorbate 24 mg zinc ascorbate 1 mg magnesium l-threonate 1 mg betaine 500 ug citric acid monohydrate 1.83 mg sodium citrate 3.67 mg) Dailymed


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EnLyte®

with DeltaFolateâ„¢

[15 mg DFE]

​JAYMAC Pharmaceuticals, LLC

Softgels (30ct bottle)

Medical Food ​For Therapeutic Use

Description


EnLyte® is a medical food for use only under medical supervision to assist MTHFR SNP (IEMs) and methylation coenzyme cofactor deficiency patients in the clinical dietary management of depression and is specially formulated to meet the distinctive nutritional requirements for these patients.

Each EnLyte® softgel capsule contains 15 mg DFE of reduced folates from DeltaFolate™. 

A recent study+ suggested that EnLyte® was effective in lowering homocystine 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.

Inactive Ingredient Section


ALSO CONTAINS: 24 mg l-ascorbate magnesium, 20 mg phospholipids, 1.5 mg elemental iron (ferrous glycine cysteinate), 1 mg l-ascorbate zinc, 1 mg l-threonate magnesium, 50 mcg adenosylcobalamin, 25 mcg thiamine pyrophosphate, 25 mcg flavin adenine dinucleotide, 25 mcg nicotinamide adenosine dinucleotide hydride, 25 mcg pyridoxal 5’ phosphate.

EXCIPIENTS: annatto, betaine, citrates, gelatin, glycerin, natural orange flavor, olive oil, piperine, purified water, sunflower lecithin, ubidecarenone (CoQ10), yellow beeswax.

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

Indications:


CLINICAL DIETARY MANAGEMENT OF MAJOR DEPRESSIVE DISORDER.

Adverse Reactions:


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 B12.

Precautions:


Folic acid, including reduced forms such as folinic acid, in daily doses above 0.1 mg may obscure the detection of B12 deficiency specifically, the administration of folic 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 and must be administered under the supervision of a licensed medical practitioner. L-methylfolate is not interchangeable with folic acid. Folic acid is not effective in some patients in impacting cerebral folate levels due to low rates of folic acid transport across the blood-brain barrier and/or low brain levels of the enzyme required to convert folic acid into a biological and functional form.

Dosage And Administration:


The usual dose is one EnLyte® softgel capsule given daily with or without food, or as directed under medical supervision. No age restrictions.

KEEP THIS OUT OF THE REACH OF CHILDREN.

Do not exceed the recommended dose.

How Supplied:


Oval, brownish orange softgel capsule with imprint ENL.

Storage:


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, Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/INDIA

​Rev July 28 2022

Package Label.principal Display Panel - 30 Softgels Bottle Label




DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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