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

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.

FUNCTIONAL EXCIPIENTS: 25 mg ascorbates3,4 (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.

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

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.

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.

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.

Oval, brownish-orange softgel capsule with imprint ENL.

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

Rx ONLY

KEEP OUT OF THE REACH OF CHILDREN.

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

MANUFACTURED FOR:

JayMac Pharmaceuticals, LLC; Sunset, LA 70584.

MANUFACTURED IN INDIA / PACKAGED IN USA

PATENTS:

Patent applications pending.

TRADEMARKS:

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

Revision (February 4, 2026)

EnBrace HR ®

with DeltaFolateTM

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