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EnBrace HR

Generic Name: prenatal/postnatal prescription folate
Dosage Form: capsule

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™
Multiphasic Soft Gelatin Capsules

Enhanced Prenatal/Postnatal
Prescription-Folate with other Dietary Ingredients
Product Code 64661-650-30
Rx

EnBrace HR 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.

*
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.
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 25 mcg
Flavin adenine dinucleotide (FAD) 25 mcg
Nicotinamide adenine dinucleotide hydride (NADH) 25 mcg
Pyridoxal 5' phosphate (P5P) 25 mcg
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

OTHER INGREDIENTS: Annatto (color), citrates, gelatin (bovine), glycerin, lecithin (sunflower), natural creamy orange (flavor), olive oil, piperine1 (bioavailability enhancer), purified water, r-5-formylTHF, ubidecarenone (trace amounts), yellow beeswax,....[and other ancillary ingredients2 as needed to ensure product stability].

Contains soy and fish (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
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 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 B12 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 1-866 280-5961.

EnBrace HR 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 dose.

How is EnBrace HR 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 64661-650-30. EnBrace HR™ is also supplied to licensed healthcare practitioners as samples, Product Code 64661-650-05.

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°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 70584

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; 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

64661-650-30
Rx

EnBraceHR

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64661-650
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE MAGNESIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 5.23 mg
LEUCOVORIN (LEUCOVORIN) LEUCOVORIN 2.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
FERROUS CYSTEINE GLYCINATE (FERROUS CATION) FERROUS CYSTEINE GLYCINATE 13.6 mg
MAGNESIUM ASCORBATE (ASCORBIC ACID) MAGNESIUM ASCORBATE 24 mg
ZINC ASCORBATE (ASCORBIC ACID) ZINC ASCORBATE 1 mg
COCARBOXYLASE (COCARBOXYLASE) COCARBOXYLASE 25 ug
FLAVIN ADENINE DINUCLEOTIDE (FLAVIN ADENINE DINUCLEOTIDE) FLAVIN ADENINE DINUCLEOTIDE 25 ug
NADH (NADH) NADH 25 ug
PYRIDOXAL PHOSPHATE ANHYDROUS (PYRIDOXAL PHOSPHATE ANHYDROUS) PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug
COBAMAMIDE (COBAMAMIDE) COBAMAMIDE 50 ug
BETAINE (BETAINE) BETAINE 500 ug
MAGNESIUM L-THREONATE (THREONIC ACID, DL-) MAGNESIUM L-THREONATE 1 mg
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug
PHOSPHATIDYL SERINE (PHOSPHATIDYL SERINE) PHOSPHATIDYL SERINE 12 mg
Inactive Ingredients
Ingredient Name Strength
ANNATTO  
SODIUM CITRATE  
CITRIC ACID MONOHYDRATE  
GELATIN  
GLYCERIN  
LECITHIN, SUNFLOWER  
ORANGE  
OLIVE OIL  
PIPERINE  
WATER  
UBIDECARENONE  
YELLOW WAX  
Product Characteristics
Color BROWN (ANNATTO) Score no score
Shape CAPSULE (oval) Size 14mm
Flavor Imprint Code ENL
Contains         
Packaging
# Item Code Package Description
1 NDC:64661-650-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/08/2015
Labeler - JAYMAC Pharmaceuticals, LLC (830767260)
Revised: 04/2015
 
JAYMAC Pharmaceuticals, LLC
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