Label: ENL (leucovorin, 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, liquid filled
- NHRIC Code(s): 64661-082-25
- Packager: Jaymac Pharma
- Category: MEDICAL FOOD
Drug Label Information
Updated December 19, 2024
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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.
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INACTIVE INGREDIENT
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:
- ADVERSE REACTIONS:
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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.
- RECOMMENDED USE:
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HOW 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.
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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/CANADA
Rev April 10, 2024 (V17)
- label
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INGREDIENTS AND APPEARANCE
ENL
leucovorin, 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, liquid filledProduct Information Product Type MEDICAL FOOD Item Code (Source) NHRIC:64661-082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN 3.5 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 082 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:64661-082-25 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date medical food 01/03/2022 Labeler - Jaymac Pharma (830767260) Registrant - Jaymac Pharma (830767260) Establishment Name Address ID/FEI Business Operations Viva Pharmaceuticals INC 253288898 manufacture