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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

with 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 Use

Multi-phasic Capsules (30ct bottle)

NDC 64661-650-30

Rx Only [DRUG]

GLUTEN-FREE

DESCRIPTION:

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.

INGREDIENTS
*
6 mg DFE folate (vitamin B9) of at least 15 mg DFE total folate
From 9 mg l-methylfolate (molar equivalent)
 Adenosylcobalamin (coenzyme B12)  50 mcg
 Formyltetrahydrofolic acid (B9-vitamer)  2.5 mg*
 Folic acid, DHF - (provitamin B9)  1 mg​*
 Levomefolic acid, magnesium salt (B12 cofactor)  7 mg

FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates1,2 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega3 complex3 [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 phosphate4 (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.

1
20% daily value (DV) of VITAMIN C, and 5% DV IRON.
2
NOT a significant source of magnesium and zinc.
3
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)
4
Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6.

MECHANISM OF ACTION

Vitamin B12[active]; Folate[prophylactic]

iNDICATIONS

EnBrace® HR is indicated in the treatment of pernicious anemias of pregnancy, and prophylactic folate supplementation.

Warning
  1. USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS.
  2. 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.
  3. Periodic examination and laboratory studies of pernicious anemia patients are essential and recommended
  4. 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.

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.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

EnBrace HR 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.

How is EnBrace HR Supplied

Oval, brownish-orange softgel capsule with ENL5 on one side, in bottles of 30 with NDC 64661-650-30.

5
Upper case

STORAGE

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.

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

PRINCIPAL DISPLAY PANEL

NDC 64661-650-30

Rx Only

EnBrace™HR™

[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

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)
Registrant - JAYMAC Pharmaceuticals, LLC (830767260)
Revised: 09/2017
 
JAYMAC Pharmaceuticals, LLC
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