DOSAGE & ADMINISTRATION SECTION.
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.
SPL UNCLASSIFIED SECTION.
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
HOW SUPPLIED SECTION.
HOW SUPPLIED Oval, brownish-orange softgel capsule with ENL Upper case on one side, in bottles of 30 with NDC 64661-650-30.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
iNDICATIONS EnBrace HR is indicated in the treatment of pernicious anemias of pregnancy, and prophylactic folate supplementation.
MECHANISM OF ACTION SECTION.
MECHANISM OF ACTION Vitamin B12 [active] ; Folate [prophylactic]
BOXED WARNING SECTION.
WARNING 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL NDC 64661-650-30 Rx Only EnBraceHR [50 mcg B12 ] [15 mg DFE folate] ANTI-PERNICIOUS ANEMIA B12-PREPARATION with 9mg DFE l-methylfolate magnesium and 6mg DFE other folates JAYMAC Pharmaceuticals, LLC 30 ct. Softgels Dye and Gluten Free Enhanced Prenatal Vitamin Supplement
DESCRIPTION: EnBrace HR is an orally administered prescription prenatal/vitamin drug for 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. 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)
PRECAUTIONS 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.
STORAGE AND HANDLING SECTION.
STORAGE Store at 20-25C (68-77F). 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 .
INACTIVE INGREDIENT SECTION.
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 dinucleotide 4 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride 4 (NADH), pyridoxal 5 phosphateContains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6. (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate 4 , ubidecarnone [antioxidant], yellow beeswax. CONTAINS FISH/KRILL/SOY. Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.