Enbrace Hr ®

The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs.

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

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

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

FUNCTIONAL EXCIPIENTS: 25 mg ascorbates^3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), flavin adenine dinucleotide⁶ (FAD), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride⁶ (NADH), at least 23.33 mg phospholipid-omega 3 complex⁵ [marine lipids], 25 mcg pyridoxal 5’ phosphate⁶ (P5P), 25 mcg thiamine pyrophosphate⁶.

OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], piperine [bioavailability enhancer], purified water, ubidecarenone [antioxidant], yellow beeswax.

¹ The form most found in mammalian liver. ² Pure amino acid, cysteinated iron chelate. ³ 20% Daily Value (DV) of VITAMIN C, and 5% DV IRON for pregnancy. ⁴ NOT a significant source of magnesium and zinc. ⁵ 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). ⁶ Contains less than 2% (<25 mcg/each) of vitamins B₁, B₂, B₃, and B₆.

Store at 20°-25°C (68°-77°F). Protect from light and moisture.

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.

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

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

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.

Oval, brownish-orange softgel capsule with imprint ENL.

Folic acid, DHF+ (B₉-Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg

Folinic acid (B₉-vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4.25 mg DFE) 2.5 mg

Levomefolic acid (B₉ & B₁₂- cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg

Vitamin B₁₂ [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg¹

FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg^2,3

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.

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

EnBrace  HR ^®

with DeltaFolate ^TM

NDC 64661-650-30

Rx Only

[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 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

FUNCTIONAL EXCIPIENTS: 25 mg ascorbates^3,4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), flavin adenine dinucleotide⁶ (FAD), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride⁶ (NADH), at least 23.33 mg phospholipid-omega 3 complex⁵ [marine lipids], 25 mcg pyridoxal 5’ phosphate⁶ (P5P), 25 mcg thiamine pyrophosphate⁶.

OTHER EXCIPIENTS: Annatto [colorant], citrates (citric, sodium) [stabilizers], gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], piperine [bioavailability enhancer], purified water, ubidecarenone [antioxidant], yellow beeswax.

¹ The form most found in mammalian liver. ² Pure amino acid, cysteinated iron chelate. ³ 20% Daily Value (DV) of VITAMIN C, and 5% DV IRON for pregnancy. ⁴ NOT a significant source of magnesium and zinc. ⁵ 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). ⁶ Contains less than 2% (<25 mcg/each) of vitamins B₁, B₂, B₃, and B₆.

Store at 20°-25°C (68°-77°F). Protect from light and moisture.

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.

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

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

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.

Oval, brownish-orange softgel capsule with imprint ENL.

Folic acid, DHF+ (B₉-Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg

Folinic acid (B₉-vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4.25 mg DFE) 2.5 mg

Levomefolic acid (B₉ & B₁₂- cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg

Vitamin B₁₂ [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg¹

FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg^2,3

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.

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

EnBrace  HR ^®

with DeltaFolate ^TM

NDC 64661-650-30

Rx Only

[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

The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs.

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

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