ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. 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.

DESCRIPTION SECTION.

DESCRIPTION:. EnBrace(R) HR is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and directr monitoring of licensed medical practitioner. EnBrace(R) HR contains small amount of iron and may be taken concurrently with iron supplementation.. INGREDIENTS:. Control-release, citrated folic acid, DHF+ (B9 Provitamin) mg1 Vitamin B12 [cobamamide] 50 mcg2 FeGC [ferrous glycine cysteinate] (1.5 mg elemental iron) 13.6 mg3 ALSO CONTAINS: Folinic acid (B9-vitamer) 2.5 mg1 Levomefolic acid (B9 B12 cofactor) 5.23 mg4 6 mg DFE folate (vitamin B9)2 The form most found in mammalian liver adjusted for stability and pH in the presence of stomach substance, is cobamamide, or vitamin B12 Pure amino acid, cysteinated iron chelate as AminoFerTM under exclusive license4 mg DFE l-methylfolate magnesium (molar equivalent) AminoFerTM (Viva Pharmaceuticals, Canada) U.S. Patent 7,341,708.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. The adult dose is one capsule daily preferably on an empty stomach.As general rule reticulocyte plasma count, folate and vitamin B12 status must be obtained prior to treatment.Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 337.662-5962.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Oval, brownish-orange softgel capsule with imprint ENL.

INACTIVE INGREDIENT SECTION.

FUNCTIONAL EXCIPIENTS: 25 mg ascorbates5,6 (24 mg magnesium l-ascorbate, mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega complex7 [marine lipids] 500 mcg betaine (trimethylglycine) [acidifier], mg magnesium l-threonate [stabilizer].OTHER EXCIPIENTS: Annatto color (as blend of annatto with stomach substance [thickener/stabilizer]) [colorant], citrates (citric, sodium) [stabilizers], flavin adenine dinucleotide (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride (NADH), pyridoxal phosphate (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate , ubidecarenone [antioxidant], yellow beeswax.5 20% daily value (DV) of VITAMIN C, and 5% DV IRON for pregnancy6 NOT significant source of magnesium and zinc7 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)8 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6 CONTAINS FISH/KRILL/SOY.Certified 3rd-partyGLUTEN-FREE.No artificial colorants. No dairy, wheat, sugar or egg.

INDICATIONS & USAGE SECTION.

iNDICATIONS:. EnBrace(R) 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.

MECHANISM OF ACTION SECTION.

MECHANISM OF ACTION:. Vitamin B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION];.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL:. EnBraceHR(TM)with DeltaFolateTMNDC 64661-650-30Rx OnlyCertified 3rd-party GLUTEN-FREE[15 mg DFE Folate][50 mcg CBI][1.5 MG FeGC]ANTI-ANEMIA PREPARATIONLow-IRONJayMac Pharmaceuticals, LLCSOFTGEL (30 ct BOTTLE)Prescription Prenatal Vitamin For Therapeutic Use. Enbrace-Label image.

PRECAUTIONS SECTION.

PRECAUTIONS:. 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 mg [emphasis added].Folic acid is not 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 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 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 mothers 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.

SPL UNCLASSIFIED SECTION.

EnBrace(R) HRwith DeltaFolate(TM)[15 mg DFE Folate ][50 mcg CBl] [1.5 mg Cys-Fe]ANTI-ANEMIA PREPARATIONLow-IRONPrescription Prenatal Vitamin For Therapeutic Use SOFTGEL (30ct bottle)NDC 64661-650-30Rx OnlyGLUTEN-FREE.

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.