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
FDA Drug Information • Also known as: EnBrace HR
- Brand Names
- EnBrace HR
- Drug Class
- Methylating Agent [EPC], Folate Analog [EPC]
- Route
- ORAL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION: EnBrace HR® is an orally administered prescription prenatal vitamin for therapeutic use formulated for adult patients who are under specific and direct monitoring of a licensed medical practitioner. EnBrace HR® contains a small amount of iron and may be taken concurrently with iron supplementation. INGREDIENTS: Folic acid, DHF+ (B 9 -Provitamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1.7 mg DFE) 1 mg Folinic acid (B 9 -vitamer). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4.25 mg DFE) 2.5 mg Levomefolic acid (B 9 & B 12 - cofactor) . . . . . . . . . . . . . . . . . . . . . . . . . . (9 mg DFE) 5.23 mg Vitamin B 12 [cobamamide] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 mcg 1 FeGC (1.5 mg elemental iron from ferrous glycine cysteinate) . . . . . . . . . . . . 13.6 mg 2,3
What Is 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 Used For?
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 and Administration
DOSAGE AND ADMINISTRATION : The recommended dosage is one (1) capsule daily, preferably on an empty stomach. Dosage may be adjusted by a healthcare provider based on individual patient needs. As a general rule reticulocyte plasma count, folate and vitamin B 12 status must be obtained prior to treatment. Do not exceed the recommended dose. Call your medical practitioner about side effects. You may report side effects by calling (866) 280-5961.
Side Effects (Adverse Reactions)
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.
How Supplied
HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL .
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.