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EnBrace® HRwith DeltaFolate™ [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 UseMulti-phasic Capsules (30ct bottle)NDC 64661-650-30Rx Only [DRUG]GLUTEN-FREE
INGREDIENTS Adenosylcobalamin (coenzyme B12) 50 mcg Formyltetrahydrofolic acid (B9-vitamer) 2.5 mg6 mg DFE folate (vitamin B9) of at least 15 mg DFE total folate Folic acid, DHF - (provitamin B9) 1 mg* Levomefolic acid, magnesium salt (B12 cofactor) 7 mgFrom 9 mg l-methylfolate (molar equivalent)
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.Rev August 2017
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.
FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates20% daily value (DV) of VITAMIN C, and 5% DV IRON.,NOT a significant source of magnesium and zinc. (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega3 complexContains 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) [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 phosphateContains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6. (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, ubidecarnone [antioxidant], yellow beeswax.CONTAINS FISH/KRILL/SOY.Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.
Mechanism Of Action
Vitamin B12[active]; Folate[prophylactic]
EnBrace® HR is indicated in the treatment of pernicious anemias of pregnancy, and prophylactic folate supplementation.
- USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.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.Periodic examination and laboratory studies of pernicious anemia patients are essential and recommended. 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.
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.
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.
Oval, brownish-orange softgel capsule with ENLUpper case on one side, in bottles of 30 with NDC 64661-650-30.
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.
* Please review the disclaimer below.