Clinical Information
Gen. Code and Des.
74012 multivit41/iron/folate8/ps-dha ORAL CAP IR DR 1.5-8.73MG
GCN and Des.
38525 multivit41/iron/folate8/ps-dha ORAL CAP IR DR 1.5-8.73MG
Strength
Dose Form
CAPSULE,IMMEDIATE, DELAY RELEASE,BIPHASE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
88280000 MULTIVITAMIN PREPARATIONS
20040400 IRON PREPARATIONS
88080000 VITAMIN B COMPLEX
Active Ingredients
14000 phosphatidylserine-docosahexaenoic acid(dha),conj.
15439 ferrous cysteine glycinate
15781 folic acid, leucovorin, levomefolate magnesium
18155 multivitamin combination no.41
Inactive Ingredients
2549 gelatin 9000708
7286 annatto
9283 beef derived (bovine)
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
SPL UNCLASSIFIED SECTION
EnBrace® HR - with DeltaFolate™ [15 mg DFE Folate ][50 mcg CBl] [1.5 mg Cys-Fe] ANTI-ANEMIA PREPARATION - Low-IRON - Prescription Prenatal Vitamin For Therapeutic Use - SOFTGEL (30ct ...
DESCRIPTION:
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 ...
INACTIVE INGREDIENT
FUNCTIONAL EXCIPIENTS: 25 mg ascorbates5,6 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 23.33 mg phospholipid-omega 3 complex7 [marine lipids] , 500 mcg betaine ...
MECHANISM OF ACTION:
Vitamin B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION];
iNDICATIONS:
EnBrace® HR is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate. Requirements of ...
PRECAUTIONS:
GENERAL: 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 ...
ADVERSE REACTIONS:
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B12. Allergic sensitization has been reported ...
DOSAGE AND ADMINISTRATION:
The adult dose is one capsule daily preferably on an empty stomach. As a general rule reticulocyte plasma count, folate and vitamin B12 status must be obtained prior to treatment. Do not exceed ...
HOW SUPPLIED:
Oval, brownish-orange softgel capsule with imprint ENL.
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.
SPL UNCLASSIFIED SECTION
Rx ONLY - 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 ...
PRINCIPAL DISPLAY PANEL:
EnBraceHR™ with DeltaFolateTM - NDC 64661-650-30 - Rx Only - Certified 3rd-party GLUTEN-FREE - [15 mg DFE Folate][50 mcg CBI][1.5 MG FeGC] ANTI-ANEMIA ...
INGREDIENTS AND APPEARANCE