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

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 September 14, 2017

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  • 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 examination and laboratory studies of pernicious anemia patients are essential and recommended.
    4. The parenteral administration of (cyano)cobalamin – or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.

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  • SPL UNCLASSIFIED SECTION

    EnLyte®

    with DeltaFolate™

    [50 mcg B12] [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]

    ANTI-PERNICIOUS ANEMIA B12-PREPARATION with B12-cofactor levomefolic acid, magnesium salt.

    Prescription Hematinic Drug For Therapeutic Use

    Softgel Capsules (30ct bottle)

    NDC 64661-711-30

    Rx Only [DRUG]

    GLUTEN-FREE

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  • DESCRIPTION

    EnLyte® is an orally administered prescription hematinic drugfor therapeutic use formulated for adult macrocytic anemia patients ages 12 and up, who are under specific direction and monitoring of vitamin B12 status by a physician

    Ingredients
    *
    6 mg DFE folate (vitamin B9) of at least 15 mg DFE total folate
    From 9 mg l-methylfolate (molar equivalent)
     Adenosylcobalamin (coenzyme B12)  50 mcg
     Formyltetrahydrofolic acid (B9-vitamer)  2.5 mg*
     Folic acid, DHF - (provitamin B9) 1 mg*
    Levomefolic acid, magnesium salt (B12 cofactor)     7 mg

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  • INACTIVE INGREDIENT

    FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron1) [colorant], 25 mg ascorbates1,2 (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-omega3 complex3 [marine lipids], 500 mcg betaine (trimethylgycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].

    OTHER EXCIPIENTS: Annatto [colorant], flavin adenine dinucleotide4 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride4 (NADH), pyridoxal 5 phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, ubidecarnone [antioxidant], yellow beeswax.

    CONTAINS FISH/KRILL/SOY.

    Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.


    1
    30% daily value (DV) of VITAMIN C, and 10% DV IRON.
    2
    NOT a significant source of magnesium and zinc.
    3
    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)
    4
    Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6
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  • MECHANISM OF ACTION:

    Vitamin B12[active]; Vitamin B9 [prevention]

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  • INDICATIONS:

    EnLyte® is indicated in the treatment of pernicious anemia, and the prevention of vitamin B9 deficiency.

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  • ADVERSE REACTIONS:

    Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.

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  • DOSAGE AND ADMINISTRATION:

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

    Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.

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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 AND HANDLING

    STORAGE:

    Store at 20°-25°C (68°-77°F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion.

    KEEP OUT OF THE REACH OF CHILDREN.

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

    MANUFACTURED FOR:

    JayMac Pharmaceuticals, LLC; Sunset, LA 70584.

    MANUFACTURED AND/OR PACKAGED IN USA/CANADA.

    PATENTS:

    US Patent No 7,935,365; and other patent applications pending.

    TRADEMARKS:

    EnLyte® is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.

    Rev August 2017

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

    NDC 64661-711-30††Rx

    EnLyte®
    with DeltaFolateTM

    (2.5mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg)

    ANTI-PERNICIOUS ANEMIA B12 - PREPARATION

    with B12-cofactor levomefolic acid, magnesium salt

    JAYMAC
    Pharmaceuticals, LLC

    SOFTGELS (30ct BOTTLE)

    Presciption Hematinic Drug for Therapeutics 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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