Label: ENBRACE HR- levomefolate magnesium, leucovorin, folic acid, ferrous cysteine glycinate, magnesium ascorbate, zinc ascorbate, cocarboxylase, flavin adenine dinucleotide, nadh, pyridoxal phosphate anhydrous, cobamamide, betaine, magnesium l-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, and phosphatidyl serine capsule, delayed release pellets

  • NDC Code(s): 64661-650-30
  • 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 June 9, 2019

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  • SPL UNCLASSIFIED SECTION

    EnBrace® HR

    with DeltaFolate™

    [15 mg DFE Folate ][50 mcg CBl] [1.5 mg FeGC]

    ANTI-ANEMIA PREPARATIONas folate, cobalamin & low-iron

    Prescription Prenatal Vitamin DrugFor Therapeutic Use

    Multi-phasic Capsules (30ct bottle)

    NDC 64661-650-30

    R x Only [DRUG]

    GLUTEN-FREE

  • DESCRIPTION:

    EnBrace® HR is an orally administered prescription prenatal vitamin drug for therapeutic use formulated to meet the unique nutritional needs of pregnancy - regardless of lactation status. EnBrace® HR may be taken by female macrocytic anemia patients that are in need of treatment and are under specific direction and monitoring of vitamin B9 and vitamin B12 status by a physician.

    EnBrace® HR is intended for women of childbearing age, and may be prescribed for women at risk of folate or cobalamin deficiency - including folate-induced perinatal and postpartum depression, and are at risk of folate-induced birth defects such as may be found with spina bifida and other neural tube defects (NTDs).

    EnBrace® HR is intended to address the increased need for metabolically-active variants of vitamin B9-vitamers in the cerebrospinal fluid, plasma, and/or red blood cells - as may be found in the SNP (Single-Nucleotide Polymorphisms) known as MTHFR (MethyleneTetraHydroFolate Reductase). EnBrace® HR achieves this through passive diffusion of these different biologically-active vitamers.

    EnBrace® HR contains a small amount of iron and may be taken concurrently with iron supplementation.

    ​INGREDIENTS:

    Control-release, citrated folic acid, DHF+ (B9 - Provitamin) 1 mg​1
    Vitamin B12 [cobamamide] 50 mcg​2
    FeGC [ferrous glycine cysteinate] (1.5 mg elemental iron) 13.6 mg​3
    ALSO CONTAINS: 
    Folinic acid (B9-vitamer) 2.5 mg​1
    Levomefolic acid (B9 & B12 - cofactor) 5.23 mg​4

    1 6 mg DFE folate (vitamin B9)

    2 The form most found in mammalian liver - adjusted for stability and pH in the presence of stomach substance, is a cobamamide, or vitamin B12

    3 Pure amino acid, cysteinated iron chelate as AminoFerTM* under exclusive license

    4 9 mg DFE l-methylfolate magnesium (molar equivalent)

    * AminoFerTM (Viva Pharmaceuticals, Canada) U.S. Patent # 7,341,708

  • INACTIVE INGREDIENT

    FUNCTIONAL EXCIPIENTS: 25 mg ascorbates5,6 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega 3 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], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide 8 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride 8 (NADH), pyridoxal 5’ phosphate 8 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate 8 , ubidecarenone [antioxidant], yellow beeswax.

    5 20% daily value (DV) of VITAMIN C, and 5% DV IRON for pregnancy

    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-partyGLUTEN-FREE.No artificial colorants. No dairy, wheat, sugar or egg.

  • MECHANISM OF ACTION:

    Vitamin B9[treatment]; Vitamin B12 [prevention]; and Iron [prophylactic].

    [Vitamin B9]

    Vitamin B9 deficiency results in megaloblastic anemia. Vitamin B9 stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias.

    Folic acid, folinic acid and l-methylfolate metabolism results in the creation of tetrahydrofolic acid by different pathways. Both folinic acid and levomefolic acid do not require dihydrofolate reductase (DHR), however folic acid does.

    [Vitamin B12]

    Vitamin B12 deficiency results in megaloblastic anemia, GI lesions, and neurological damage that begins with an inability to produce myelin and is followed by gradual degeneration of the axon and nerve head. Vitamin B12 has hematopoietic activity apparently identical to that of the anti-anemia factor in purified liver extract.

    Inborn errors of metabolism (IEMs) - such as methyltetrahydrofolate reductase (MTHFR), may also inhibit cobalamin intracellular conversion due to impaired ability to metabolize folic acid.

  • iNDICATIONS:

    EnBrace® HR is indicated in the treatment of folate-induced macrocytic anemias before, during or after pregnancy including megaloblastic anemias, and the prevention of cobalamin deficiency.

    Requirements of vitamin B9 and/or vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.

  • 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.

  • PRECAUTIONS​:

    GENERAL:

    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].

    Folic acid is not a substitute for vitamin B12 - although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage. Specifically, vitamin B12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when folate therapy is used as the only hematopoietic agent.

    Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate 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.

    DRUG INTERACTIONS:

    Colchicine, para-aminosalicylic acid, and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

    CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

    There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 or folate is carcinogenic. Pernicious anemia is associated with increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with vitamin B12.

    PREGNANCY, NURSING MOTHERS, PEDIATRIC USE:

    Vitamin B9 and vitamin B12 are essential vitamins and requirements are increased during pregnancy. Amounts of vitamin B9 and vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science - National Research Council for lactating women should be consumed during pregnancy.

    Vitamin B12 and vitamin B9 appear in the milk of nursing mothers in concentrations which approximate the mother’s vitamin B12 and vitamin B9 blood level. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academies of Science - National Research Council for lactating women should be consumed during lactation.

    Intake in pediatric patients should be in the amount recommended by the Food and Nutrition Board, National Academy of Science - National Research Council.

  • 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 folic acid.

  • DOSAGE AND ADMINISTRATION​:

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

    As a general rule reticulocyte plasma count, folate and vitamin B12 status must be obtained prior to treatment.

    Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 337.662-5962.

  • HOW SUPPLIED:

    Oval, brownish-orange softgel capsule with “ENL”9 on one side, in bottles of 30 with NDC 64661-650-30.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Rx Only [DRUG]

    Caution: Federal law prohibits dispensing without a prescription.

    KEEP OUT OF THE REACH OF CHILDREN.

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

    9Upper case.

    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:

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

    Revision 3(April 2019)

  • PRINCIPAL DISPLAY PANEL:

    NDC 64661-650-30

    Rx Only

    Certified 3rd-party GLUTEN-FREE

    WITH DeltaFolateTMEnBrace™HR™

    [15 mg DFE Folate][50 mcg CBI][1.5 MG FeGC]

    ANTI-ANEMIA PREPARATION

    as folate, cobalamin & low-iron

    JAYMAC
    Pharmaceuticals, LLC

    SOFTGEL (30 ct BOTTLE)

    Prescription Prenatal/Vitamin Drug

    For Therapeutic Use

    enbrace pi label

  • INGREDIENTS AND APPEARANCE
    ENBRACE HR 
    levomefolate magnesium, leucovorin, folic acid, ferrous cysteine glycinate, magnesium ascorbate, zinc ascorbate, cocarboxylase, flavin adenine dinucleotide, nadh, pyridoxal phosphate anhydrous, cobamamide, betaine, magnesium l-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, and phosphatidyl serine capsule, delayed release pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64661-650
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID5.23 mg
    LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE13.6 mg
    MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE24 mg
    ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE1 mg
    COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE25 ug
    FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE25 ug
    NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH25 ug
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS25 ug
    COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE50 ug
    BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE500 ug
    MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, DL- - UNII:NTD0MI8XRT) MAGNESIUM L-THREONATE1 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
    Inactive Ingredients
    Ingredient NameStrength
    ANNATTO (UNII: 6PQP1V1B6O)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    PIPERINE (UNII: U71XL721QK)  
    WATER (UNII: 059QF0KO0R)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    ColorBROWN (ANNATTO) Scoreno score
    ShapeCAPSULE (oval) Size14mm
    FlavorImprint Code ENL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64661-650-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER08/12/2011
    Labeler - JAYMAC Pharmaceuticals, LLC (830767260)
    Registrant - JAYMAC Pharmaceuticals, LLC (830767260)