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  5. Label Information: Enbrace Hr

FDA Label for Enbrace Hr

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION:
    3. INACTIVE INGREDIENT
    4. MECHANISM OF ACTION
    5. INDICATIONS
    6. WARNING
    7. PRECAUTIONS
    8. ADVERSE REACTIONS
    9. DOSAGE AND ADMINISTRATION
    10. HOW SUPPLIED
    11. STORAGE
    12. PRINCIPAL DISPLAY PANEL

Enbrace Hr Product Label

The following document was submitted to the FDA by the labeler of this product Jaymac Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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

INGREDIENTS
 Adenosylcobalamin (coenzyme B12) 50 mcg
 Formyltetrahydrofolic acid (B9-vitamer) 2.5 mg

6 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 mg

From 9 mg l-methylfolate (molar equivalent)

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


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.


Inactive Ingredient



FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron3) [colorant], 25 mg ascorbates

20% 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 complex

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)

[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 phosphate

Contains 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.


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



  • 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.


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.


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 Supplied



Oval, brownish-orange softgel capsule with ENL

Upper case

on one side, in bottles of 30 with NDC 64661-650-30.


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.


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


* Please review the disclaimer below.