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

  • NDC Code(s): 64661-711-30
  • Packager: Jaymac Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 17, 2019

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    WARNINGS:

    1. USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.
    2. Some patients afflicted with pernicious anemia may or not respond to the orally ingested vitamin B12, and there is no known way to predict which patients may respond and which patients may cease to respond.
    3. Periodic examinations and laboratory studies of pernicious anemia patients are essential and recommended.
    4. The parental administration of (cyano)cobalamin – or vitamin B12, is generally recognized as fully effective treatment of pernicious anemia. Parental alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.

    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.

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  • SPL UNCLASSIFIED SECTION

    EnLyte®

    with DeltaFolate™

    [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]​[50 mcg CBI][1.5 mg FeGC]

    ANTI-ANEMIA PREPARATION

    ​as folate, cobalamin & iron

    ​Certified 3rd-party GLUTEN-FREE

    ​JAYMAC Pharmaceuticals, LLC

    Softgels (30ct bottle)

    Prescription ​Folate/Hematinic Drug​For Therapeutic Use

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  • ​Description

    EnLyte® is an orally administered prescription folate/hematinic drug for therapeutic use formulated for adult macrocytic anemia patients - ages 12 and up, who are under specific direction and monitoring of folate, cobalamin and iron status by a physician. EnLyte®, through passive diffusion of folate-vitamers, is intended to address the increased need for metabolically-active forms of folate in the cerebrospinal fluid, plasma, and/or red blood cells in patients with MTHFR (at alleles C667T, A1298C and/or G1793A) and/or macrocytic anemia. EnLyte®may be useful in patients at risk of depression due to a deficiency of folate and/or cobalamin.EnLyte®may be taken by women of childbearing age. EnLyte®may be taken by geriatric patients where compliance is an issue.

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  • INACTIVE INGREDIENT

    FUNCTIONAL EXCIPIENTS: 25 mg ascorbates 5,6 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates) [stabilizers], at least 23.33 mg phospholipid-omega complex7 [marine lipids], 500 mcg betaine (trimethylglycine) [acidifier], 1 mg magnesium l-threonate [stabilizer]

    OTHER EXCIPIENTS: "Annatto color" (as a blend of annatto with stomach substance [thickener/stabilizer]) [colorant], flavin adenine dinucleotide 8 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], nicotinamide adenine dinucleotide hydride 8 (NADH), pyridoxal 5’ phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate 8, ubidecarenone [antioxidant], yellow beeswax.

    5 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics

    6 NOT a significant source of magnesium and zinc.

    7 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)

    8 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.

    CONTAINS FISH/KRILL/SOY. Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.

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  • INDICATIONS:

    EnLyte® is indicated in the treatment of folate-induced macrocytic anemias – including megaloblastic anemias, resulting from deficiency - including megaloblastic anemias, and the prevention of cobalamin deficiency. EnLyte® is indicated in the maintenance of normal hematologic status (hematopoiesis) as well as supplement for other folate and cobalamin deficiencies.

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  • ADVERSE REACTIONS:

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

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  • ​PRECAUTIONS:

    0.1 mg or more of folic acid daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. The safe tolerable limit for folic acid (in preparations) is 1 mg [emphasis added].

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  • 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.

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  • HOW SUPPLIED:

    Oval, brownish-orange softgel capsule with “ENL” 7 on one side, in bottles of 30 with NDC 64661-711-30.

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  • ​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 April 2019

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label

    NDC 64661-711-30

    Rx Only

    EnLyte®
    with DeltaFolateTM

    (2.5mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg [50 mcg CBI][1.5 mg FeGC]

    ANTI-ANEMIA PREPARATION

    ​as folate, cobalamin & iron

    ​Certified 3rd-party GLUTEN-FREE

    JAYMAC
    Pharmaceuticals, LLC

    SOFTGELS (30ct BOTTLE)

    Presciption Folate/Hematinic Drug

    ​For Therapeutic Use

    PRINCIPAL DISPLAY PANEL - 30 tablets

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  • 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 pellets
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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 NDC:64661-711-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/01/2011
    Labeler - Jaymac Pharmaceuticals LLC (830767260)
    Registrant - Jaymac Pharmaceuticals LLC (830767260)
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