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

  • Category: MEDICAL FOOD

Drug Label Information

Updated December 19, 2024

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  • 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)

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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 filled
    Product Information
    Product TypeMEDICAL FOODItem Code (Source)NHRIC:64661-082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN3.5 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 082
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:64661-082-2530 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    medical food01/03/2022
    Labeler - Jaymac Pharma (830767260)
    Registrant - Jaymac Pharma (830767260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Viva Pharmaceuticals INC253288898manufacture