INGREDIENTS: Each soft gelatin capsule contains the following dietary ingredients *: L-methylfolate (as L-methylfolate magnesium)

Transcription

1 ENBRACE HR- levomefolate magnes ium, leucovorin, folic acid, ferrous cys teine glycinate, magnes ium as corbate, zinc as corbate, cocarboxylas e, flavin adenine dinucleotide, nadh, pyridoxal phos phate anhydrous, cobamamide, betaine, magnes ium l-threonate, 1,2- docos ahexanoyl-s n-glycero-3-phos phos erine calcium, 1,2-icos apentoyl-s n-glycero-3- phosphoserine calcium, and phosphatidyl serine capsule, delayed release pellets JAYMAC Pharmaceuticals, LLC 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 EnBrace HR Multiphas ic Soft Gelatin Caps ules Enhanced Prenatal/Postnatal Prescription-Folate with other Dietary Ingredients Product Code R x DESCRIPTION EnBrace HR is an orally administered enhanced prescription-folate product with other dietary ingredients formulated to improve the nutritional status of "high-risk" patients before, during, and after pregnancy. EnBrace HR is an oval, annatto-colored, multiphasic soft gelatin capsule imprinted with "ENL" on one side. EnBrace HR should be administered only under the supervision and direction of a licensed medical practitioner. INGREDIENTS: Each soft gelatin capsule contains the following dietary ingredients *: L-methylfolate (as L-methylfolate magnesium) 5.23 mg Folinic acid 2.5 mg Folic Acid, USP [as controlled-release citrated-pteroylmonoglutamic acid] 1 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron) from amino acid chelate 13.6 mg Ascorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate] 25 mg Thiamine pyrophosphate Flavin adenine dinucleotide (FAD) Nicotinamide adenine dinucleotide hydride (NADH) Pyridoxal 5' phosphate (P5P) Adenosylcobalamin 50 mcg Betaine (trimethylglycine) 500 mcg L-threonate magnesium 1 mg Omega-3 Fatty Acids PS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca 6.4 mg PS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca 800 mcg Phosphatidylserine 12 mg * Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner. Value is an estimated range based on the concentration of the amino acid chelate +/- 1mg to achieve 1.5mg of elemental iron. OTHER INGREDIENTS: Annatto (color), citrates, gelatin (bovine), glycerin, lecithin (sunflower), 1

2 natural creamy orange (flavor), olive oil, piperine (bioavailability enhancer), purified water, r-5- formylthf, ubidecarenone (trace amounts), yellow beeswax,...[and other ancillary ingredients 2 as needed to ensure product stability]. Contains s oy and fis h (blue whiting and herring). However, the soy and fish derived omega-3 fatty acids used in EnBrace HR do not contain detectable levels of soy and fish protein due to an extensive purification process. Nevertheless, EnBrace HR has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Patients with allergic tendencies to any of these substances should use discretion and consult their healthcare practitioner for advice. EnBrace HR is dye free, gluten free and does not contain any artificial flavors or sweeteners. EnBrace HR contains bovine gelatin. 1 1 Bioavailability enhancer piperine as BioPerine is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585. MECHANISM OF ACTION EnBrace HR supplies an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry. INDICATIONS EnBrace HR is indicated to improve the nutritional status in "high-risk" patients who may benefit from enhanced folate supplementation prior to conception and during pregnancy, as determined by a licensed healthcare practitioner. EnBrace HR contains over 1000% of the Daily Value (DV) of folate and 600% of DV for cobalamin for pregnant and lactating women, which may be important depending on previous pregnancy (history of a Neural Tube Defect (NTD)-affected pregnancy), genetic disposition (MTHFR polymorphisms, etc.), and acquired factors. EnBrace HR is also indicated for the clinical dietary management of metabolic imbalances associated with depression. EnBrace HR may be prescribed to increase folate levels in lactating or non-lactating women who are at risk of postpartum depression, depression before or during a pregnancy, and/or women of childbearing age who may become pregnant and/or are planning to become pregnant. EnBrace HR should be administered only under the supervision and direction of a licensed medical practitioner. CONTRAINDICATIONS EnBrace HR is contraindicated in patients with a known hypersensitivity to any of the ingredients. WARNINGS Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications

3 may interfere with folate metabolism. Folinic acid may enhance the toxicity of fluorouracil. PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Ingestion of more than 3 grams of omega-3 fatty acids (such as ALA, EPA, and DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day. ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. It is important to always contact your healthcare practitioner if you experience any side effects. To report SUSPECTED ADVERSE REACTIONS, contact JAYMAC Pharmaceuticals, LLC at DOSAGE AND ADMINISTRATION The usual adult dose is one soft gelatin capsule daily with or without food, or as prescribed by a licensed healthcare practitioner. Children under twelve should consult a healthcare practitioner. Do not exceed the recommended dos e. HOW SUPPLIED EnBrace HR is supplied as oval, annatto-colored soft gelatin capsules with "ENL" on one side, in bottles of 30 softgels with Product Code EnBrace HR is also supplied to licensed healthcare practitioners as samples, Product Code STORAGE Store at C (68-77 F); excursions permitted to C (59-86 F) [See USP Controlled Room Temperature.] Protect from light and moisture. 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 MANUFACTURED FOR: JAYMAC Pharmaceuticals, LLC Sunset, LA MADE IN CANADA PATENTS: US Patent Nos. 7,935,365; 5,965,413; 7,341,708; 6,054,585; 5,972,382; 5,744,161;

4 5,536,506; and other patent applications pending. TRADEMARKS: EnBrace HR is a trademark of JAYMAC Pharmaceuticals, LLC (Sunset, Louisiana, USA). L-methylfolate magnesium is under license from Viva Pharmaceutical Inc. (Canada). Rev. 04/15 PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label R x EnBrace HR Enhanced Prenatal/Postnatal Folate Supplement JAYMAC Pharmaceuticals, LLC 30 ct. Softgels Dye and Gluten Free Enhanced Prenatal Vitamin Supplement ENBRACE HR 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 Product Information Product T ype HUMAN PRESCRIPTION DRUG Ite m Code (Source ) NDC: Route of Ad minis tration ORAL Active Ing redient/active Moiety

5 Ing redient Name Basis o f Streng th Streng th LEVO MEFO LATE MAGNESIUM (UNII: 1VZZ6 2R0 8 1) (LEVOMEFOLIC ACID - UNII:8 S9 5DH25XC) LEVOMEFOLIC ACID LEUCO VO RIN (UNII: Q573I9 DVLP) (LEUCOVORIN - UNII:Q573I9 DVLP) LEUCOVORIN 2.5 mg FO LIC ACID (UNII: 9 35E9 7BOY8 ) (FOLIC ACID - UNII:9 35E9 7BOY8 ) FOLIC ACID 1 mg FERRO US CYSTEINE GLYCINATE (UNII: 8 B4OP7RK5N) (FERROUS CATION - UNII:GW OWR) MAGNESIUM ASCO RBATE (UNII: 0 N1G ) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R) FERROUS CYSTEINE GLYCINATE MAGNESIUM ASCORBATE ZINC ASCO RBATE (UNII: 9 TI35313XW) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R) ZINC ASCORBATE 1 mg CO CARBO XYLASE (UNII: Q Y) (COCARBOXYLASE - UNII:Q Y) COCARBOXYLASE 25 ug FLAVIN ADENINE DINUCLEO TIDE (UNII: ZC44YTI8 KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8 KK) FLAVIN ADENINE DINUCLEOTIDE NADH (UNII: 4J24DQ ) (NADH - UNII:4J24DQ ) NADH 25 ug PYRIDO XAL PHO SPHATE ANHYDRO US (UNII: F0 6 SGE49 M6 ) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F0 6 SGE49 M6 ) PYRIDOXAL PHOSPHATE ANHYDROUS CO BAMAMIDE (UNII: F0 R1QK73KB) (COBAMAMIDE - UNII:F0 R1QK73KB) COBAMAMIDE 50 ug 5.23 mg 13.6 mg BETAINE (UNII: 3SCV18 0 C9 W) (BETAINE - UNII:3SCV18 0 C9 W) BETAINE 50 0 ug MAGNESIUM L-THREO NATE (UNII: 1Y26 ZZ0 OTM) (THREONIC ACID, DL- - UNII:NTD0 MI8 XRT) 1,2 -DO CO SAHEXANO YL-SN-GLYCERO -3 -PHO SPHO SERINE CALCIUM (UNII: 6 WJM73T46 K) (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:DVY0 7ILF1W) 1,2 -ICO SAPENTO YL-SN-GLYCERO -3 -PHO SPHO SERINE CALCIUM (UNII: 9 ABD9 DRK7B) (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:C30 19 D8 IIA) PHO SPHATIDYL SERINE (UNII: 39 4XK0 IH40 ) (PHOSPHATIDYL SERINE - UNII:39 4XK0 IH40 ) MAGNESIUM L-THREONATE 1,2-DOCOSAHEXANOYL-SN- GLYCERO-3-PHOSPHOSERINE CALCIUM 1,2-ICOSAPENTOYL-SN- GLYCERO-3-PHOSPHOSERINE CALCIUM PHOSPHATIDYL SERINE 24 mg 25 ug 25 ug 1 mg 6.4 mg ug 12 mg Inactive Ing redients Ing redient Name ANNATTO (UNII: 6 PQP1V1B6 O) SO DIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MO NO HYDRATE (UNII: PHW8 QP) GELATIN (UNII: 2G8 6 QN327L) GLYCERIN (UNII: PDC6 A3C0 OX) LECITHIN, SUNFLO WER (UNII: 8 34K0 WOS5G) O RANGE (UNII: 5EVU0 4N5QU) O LIVE O IL (UNII: 6 UYK2W1W1E) PIPERINE (UNII: U71XL721QK) WATER (UNII: 0 59 QF0 KO0 R) UBIDECARENO NE (UNII: EJ27X76 M46 ) YELLO W WAX (UNII: 2ZA36 H0 S2V) Streng th Product Characteristics Color BROWN (ANNATTO) S core no sco re Shape CAPSULE (o val) Siz e 14mm Flavor Imp rint Cod e ENL Contains

6 Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC: in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date UNAPPROVED DRUG OTHER 0 4/0 8 /20 15 Labeler - JAYMAC Pharmaceuticals, LLC ( ) Revised: 4/2015 JAYMAC Pharmaceuticals, LLC