ENLYTE- leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine capsule, delayed release pellets 
Jaymac Pharma

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EnLyte®with DeltaFolateTM

EnLyte®

with DeltaFolate™

[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.

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

EnLyte

ENLYTE 
leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine capsule, delayed release pellets
Product Information
Product TypeMEDICAL FOODItem Code (Source)NHRIC:64661-711
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN2.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID7 mg
FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE13.6 mg
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 6WJM73T46K) (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:DVY07ILF1W) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM6.4 mg
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 9ABD9DRK7B) (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:C3019D8IIA) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM800 ug
PHOSPHATIDYL SERINE (UNII: 394XK0IH40) (PHOSPHATIDYL SERINE - UNII:394XK0IH40) PHOSPHATIDYL SERINE12 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS25 ug
FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE25 ug
NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH25 ug
COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE50 ug
COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE25 ug
MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE24 mg
ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE1 mg
MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, L- - UNII:75B0PMW2JF) MAGNESIUM L-THREONATE1 mg
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE500 ug
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1.83 mg
SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE3.67 mg
Inactive Ingredients
Ingredient NameStrength
ANNATTO (UNII: 6PQP1V1B6O)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PIPERINE (UNII: U71XL721QK)  
WATER (UNII: 059QF0KO0R)  
UBIDECARENONE (UNII: EJ27X76M46)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Product Characteristics
ColorBROWN (annatto) Scoreno score
ShapeOVALSize14mm
FlavorORANGE (creamy orange) Imprint Code ENL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:64661-711-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
medical food08/12/2011
Labeler - Jaymac Pharma (830767260)
Registrant - Jaymac Pharma (830767260)
Establishment
NameAddressID/FEIBusiness Operations
Ocean Healthcare Pvt Ltd873673519manufacture

Revised: 11/2023
 
Jaymac Pharma