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 DeltaFolateTM plus 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 MTHFr patients in the clinical dietary managemetnn of depression and is specially formulated to meet the distinctive nutritional requirement for these patients.

Each ENLTM capsule contains 15 mg DFE of reduced folates from DeltaFolateTM plus adenosylcobalamin.

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

OTHER INGREDIENTS: Annatto [colorant], 500 mcg betaine (trimethylglycine), at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates), 25 mcg flavin adenine dinucleotide (reduced vitamin B2), cysteinated ferrous chelate (1.5 mg elemental iron), gelatin (bovine), glycerine, 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride (reduced vitamin B3), piperine, plant lipids (sunflower), purified water, 25 mcg pyridoxal 5’ phosphate (reduced vitamin B6), 25 mcg thiamine pyrophosphate (reduced vitamin B1), ubidecarenone, yellow beeswax. [Coenzyme B12 is the primary form most found in mammalian liver. 2Vitamer of B12 cofactor, l-methylfolate. 3Pure amino acid, cysteinated iron chelate. 4 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics. 5 Contains at least 12 mg phosphatidylserine (PS)– of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca).]

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

INDICATIONS:

CLINICAL DIETARY MANAGEMENT OF MAJOR DEPRESSIVE DISORDER

ADVERSE REACTIONS:

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B12. Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.

​PRECAUTIONS:

0.1 mg or more of vitamin B9 daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. Exclusive use of vitamin B9 in treating vitamin B12-deficient macrocytic anemia could result in progressive and irreversible neurological damage. Specifically, vitamin B12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when vitamin B9 therapy is used as the only hematopoietic agent. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B9 deficiency. Indiscriminate administration may mask the true diagnosis. A dietary deficiency of only vitamin B12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.

DOSAGE AND ADMINISTRATION:

The adult dose is one capsule daily preferably on an empty stomach.

Call your medical practitioner about side effects.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:

Oval, brownish-orange softgel capsule with imprint 082.

​STORAGE:

STORAGE: Store at 20°-25° C (68°-77° F)

(Tamper Evident: Do not use if seal is broken or missing.)

JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/CANADA

​Rev DEC 2021 v10

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