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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 1, 2022

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  • SPL UNCLASSIFIED SECTION

    EnBrace® HR

    with DeltaFolate™

    [15 mg DFE Folate ][50 mcg CBl] [1.5 mg Cys-Fe]

    ANTI-ANEMIA PREPARATION

    Low-IRON

    Prescription Prenatal Vitamin For Therapeutic Use

    SOFTGEL (30ct bottle)

    NDC 64661-650-30

    Rx Only

    GLUTEN-FREE

  • DESCRIPTION:

    EnBrace® HR is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and directr monitoring of a licensed medical practitioner.  

    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 B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION];

  • iNDICATIONS:

    EnBrace® HR is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate.

    Requirements of vitamin B9 and/or vitamin B12 in excess of normal due to pregnancy can usually be met with oral supplementation.

  • 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 imprint ENL.

  • 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

    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 other patent applications pending.

    TRADEMARKS:

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

    Revision (Dec 27, 2021)

  • PRINCIPAL DISPLAY PANEL:

    EnBraceHR

    with DeltaFolateTM

    NDC 64661-650-30

    Rx Only

    Certified 3rd-party GLUTEN-FREE

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

    ANTI-ANEMIA PREPARATION

    Low-IRON

    JayMac Pharmaceuticals, LLC

    SOFTGEL (30 ct BOTTLE)

    Prescription Prenatal Vitamin For Therapeutic Use

    Enbrace-Label image

  • 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 Pharma (830767260)
    Registrant - Jaymac Pharma (830767260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ocean Healthcare Pvt Ltd873673519manufacture(64661-650)