Generic Name: prenatal/postnatal prescription folate
Dosage Form: capsule
Medically reviewed on September 1, 2017
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.
[50 mcg B12] [15 mg DFE Folate]
ANTI-PERNICIOUS ANEMIA B12-PREPARATION with 9mg DFE l-methylfolate magnesium and 6mg DFE other folates.
Prescription Prenatal/Vitamin DrugFor Therapeutic Use
Multi-phasic Capsules (30ct bottle)
Rx Only [DRUG]
EnBrace® HR is an orally administered prescription prenatal/vitamindrugfor therapeutic use formulated for female macrocytic anemia patients that are in need of treatment, and are under specific direction and monitoring of vitamin B12 status by a physician. EnBrace® HR is intended for women of childbearing age who are – or desire to become, pregnant.
|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†|
FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates1,2 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], 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], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide4 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride4 (NADH), pyridoxal 5 phosphate4 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, ubidecarnone [antioxidant], yellow beeswax.
Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.
- 20% daily value (DV) of VITAMIN C, and 5% DV IRON.
- NOT a significant source of magnesium and zinc.
- 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)
- Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.
MECHANISM OF ACTION
Vitamin B12[active]; Folate[prophylactic]
EnBrace® HR is indicated in the treatment of pernicious anemias of pregnancy, and prophylactic folate supplementation.
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 vitamin folic acid is 1 mg.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
EnBrace HR 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.
How is EnBrace HR Supplied
Oval, brownish-orange softgel capsule with ENL5 on one side, in bottles of 30 with NDC 64661-650-30.
- Upper case
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.
JayMac Pharmaceuticals, LLC; Sunset, LA 70584.
MANUFACTURED AND/OR PACKAGED IN USA/CANADA.
US Patent No 7,935,365; and other patent applications pending.
EnBrace® HR is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.
Rev August 2017
PRINCIPAL DISPLAY PANEL
[50 mcg B12 ] [15 mg DFE folate]
ANTI-PERNICIOUS ANEMIA B12-PREPARATION
with 9mg DFE l-methylfolate magnesium and 6mg DFE other folates
30 ct. Softgels • Dye and Gluten Free
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
|Labeler - JAYMAC Pharmaceuticals, LLC (830767260)|
|Registrant - JAYMAC Pharmaceuticals, LLC (830767260)|