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

ENL by

Drug Labeling and Warnings

ENL by is a Other medication manufactured, distributed, or labeled by Jaymac Pharma, Viva Pharmaceuticals INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ENLTM

with reduced folate and adenosylcobalamin

[50 mg CBl] [15 mg DFE Folate]

​JAYMAC Pharmaceuticals, LLC

Softgels (30ct bottle)

Medical Food​ For Therapeutic Use

​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.

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:

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 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.

RECOMMENDED USE:

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 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:

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

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 filled

Product 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