Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL .; PRINCIPAL DISPLAY PANEL: EnBrace HR ™ with DeltaFolate TM NDC 64661- 650 -30 Rx Only Certified 3rd-party GLUTEN-FREE [15 mg DFE Folate] [50 mcg CBI][1.5 MG FeGC] ANTI-ANEMIA PREPARATION Low-IRON JayMac Pharmaceuticals, LLC SOFTGEL (30 ct BOTTLE) Prescription Prenatal Vitamin For Therapeutic Use Enbrace-Label image
- HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL .
- PRINCIPAL DISPLAY PANEL: EnBrace HR ™ with DeltaFolate TM NDC 64661- 650 -30 Rx Only Certified 3rd-party GLUTEN-FREE [15 mg DFE Folate] [50 mcg CBI][1.5 MG FeGC] ANTI-ANEMIA PREPARATION Low-IRON JayMac Pharmaceuticals, LLC SOFTGEL (30 ct BOTTLE) Prescription Prenatal Vitamin For Therapeutic Use Enbrace-Label image
Overview
EnBrace® HR is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and directr monitoring of a licensed medical practitioner. EnBrace® HR contains a small amount of iron and may be taken concurrently with iron supplementation. INGREDIENTS: Control-release, citrated folic acid, DHF+ (B 9 - Provitamin) 1 mg 1 Vitamin B 12 [cobamamide] 50 mcg 2 FeGC [ferrous glycine cysteinate] (1.5 mg elemental iron) 13.6 mg 3 ALSO CONTAINS: Folinic acid (B 9 -vitamer) 2.5 mg 1 Levomefolic acid (B 9 & B 12 - cofactor) 5.23 mg 4 1 6 mg DFE folate (vitamin B 9 ) 2 The form most found in mammalian liver - adjusted for stability and pH in the presence of stomach substance, is a cobamamide, or vitamin B 12 3 Pure amino acid, cysteinated iron chelate as AminoFerTM* under exclusive license 4 9 mg DFE l-methylfolate magnesium (molar equivalent) * AminoFerTM (Viva Pharmaceuticals, Canada) U.S. Patent # 7,341,708
Indications & Usage
iNDICATIONS: EnBrace® HR is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate. Requirements of vitamin B 9 and/or vitamin B 12 in excess of normal due to pregnancy can usually be met with oral supplementation.
Dosage & Administration
: The adult dose is one capsule daily preferably on an empty stomach . As a general rule reticulocyte plasma count, folate and vitamin B 12 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.
Warnings & Precautions
No warnings available yet.
Adverse Reactions
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Storage & Handling
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.