Label: 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
- NHRIC Code(s): 64661-711-30
- Packager: Jaymac Pharma
- Category: MEDICAL FOOD
- DEA Schedule: None
- Marketing Status: MEDICAL FOOD
Drug Label Information
Updated December 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
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: 50 mcg adenosylcobalamin (vitamin B12) and 15 mg DFE of reduced folates (from 7 mg l-methylfolate magnesium, 2.5 mg folinic acid, and 1 mg folic acid).
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.
Ingredients: Olive oil, gelatin, glycerin, 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 iron (from ferrous glycine cysteinate), folic acid, 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).
CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.Medical foods are intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.
- INDICATIONS:
- ADVERSE REACTIONS:
-
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.
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
-
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, 2085 I-49 S. Service Rd Sunset, LA 70584
MANUFACTURED AND/OR PACKAGED IN USA/INDIA
Rev Nov 8 2023 (V9)
- WARNING:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 SOFTGELS Bottle Label
-
INGREDIENTS AND APPEARANCE
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 pelletsProduct Information Product Type MEDICAL FOOD Item Code (Source) NHRIC:64661-711 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN 2.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 7 mg FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE 13.6 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 CALCIUM 6.4 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 CALCIUM 800 ug PHOSPHATIDYL SERINE (UNII: 394XK0IH40) (PHOSPHATIDYL SERINE - UNII:394XK0IH40) PHOSPHATIDYL SERINE 12 mg PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE 25 ug NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 25 ug COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE 50 ug COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE 25 ug MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE 24 mg ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE 1 mg MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, L- - UNII:75B0PMW2JF) MAGNESIUM L-THREONATE 1 mg BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 500 ug CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1.83 mg SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE 3.67 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (annatto) Score no score Shape OVAL Size 14mm Flavor ORANGE (creamy orange) Imprint Code ENL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:64661-711-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date medical food 08/12/2011 Labeler - Jaymac Pharma (830767260) Registrant - Jaymac Pharma (830767260) Establishment Name Address ID/FEI Business Operations Ocean Healthcare Pvt Ltd 873673519 manufacture