Enbrace Hr Recall
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Questions & Answers
Side Effects & Adverse Reactions
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.
Folinic acid may enhance the toxicity of fluorouracil.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
EnBrace HR™ is indicated to improve the nutritional status in "high-risk" patients who may benefit from enhanced folate supplementation prior to conception and during pregnancy, as determined by a licensed healthcare practitioner. EnBrace HR™ contains over 1000% of the Daily Value (DV) of folate and 600% of DV for cobalamin for pregnant and lactating women, which may be important depending on previous pregnancy (history of a Neural Tube Defect (NTD)-affected pregnancy), genetic disposition (MTHFR polymorphisms, etc.), and acquired factors.
EnBrace HR™ is also indicated for the clinical dietary management of metabolic imbalances associated with depression. EnBrace HR™ may be prescribed to increase folate levels in lactating or non-lactating women who are at risk of postpartum depression, depression before or during a pregnancy, and/or women of childbearing age who may become pregnant and/or are planning to become pregnant.
EnBrace HR™ should be administered only under the supervision and direction of a licensed medical practitioner.
There is currently no drug history available for this drug.
EnBrace HR™ is an orally administered enhanced prescription-folate product with other dietary ingredients formulated to improve the nutritional status of "high-risk" patients before, during, and after pregnancy. EnBrace HR™ is an oval, annatto-colored, multiphasic soft gelatin capsule imprinted with "ENL" on one side. EnBrace HR™ should be administered only under the supervision and direction of a licensed medical practitioner.
|* Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner. † Value is an estimated range based on the concentration of the amino acid chelate +/- 1mg to achieve 1.5mg of elemental iron.|
|INGREDIENTS: Each soft gelatin capsule contains the following dietary ingredients*:|
|L-methylfolate (as L-methylfolate magnesium)||5.23 mg|
|Folinic acid||2.5 mg|
|Folic Acid, USP [as controlled-release citrated-pteroylmonoglutamic acid]||1 mg|
|FeGC as ferrous glycine cysteinate (1.5 mg elemental iron) from amino acid chelate||13.6 mg†|
|Ascorbates [as 24 mg magnesium ascorbate and 1 mg zinc ascorbate]||25 mg|
|Thiamine pyrophosphate||25 mcg|
|Flavin adenine dinucleotide (FAD)||25 mcg|
|Nicotinamide adenine dinucleotide hydride (NADH)||25 mcg|
|Pyridoxal 5' phosphate (P5P)||25 mcg|
|Betaine (trimethylglycine)||500 mcg|
|L-threonate magnesium||1 mg|
|Omega-3 Fatty Acids|
|PS-DHA as phosphatidylserine-docosahexaenoic acid from PS-DHA-Ca||6.4 mg|
|PS-EPA as phosphatidylserine-eicosapentaenoate acid from PS-EPA-Ca||800 mcg|
OTHER INGREDIENTS: Annatto (color), citrates, gelatin (bovine), glycerin, lecithin (sunflower), natural creamy orange (flavor), olive oil, piperine1 (bioavailability enhancer), purified water, r-5-formylTHF, ubidecarenone (trace amounts), yellow beeswax,....[and other ancillary ingredients2 as needed to ensure product stability].
Contains soy and fish (blue whiting and herring). However, the soy and fish derived omega-3 fatty acids used in EnBrace HR™ do not contain detectable levels of soy and fish protein due to an extensive purification process. Nevertheless, EnBrace HR™ has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Patients with allergic tendencies to any of these substances should use discretion and consult their healthcare practitioner for advice.
EnBrace HR™ is dye free, gluten free and does not contain any artificial flavors or sweeteners. EnBrace HR™ contains bovine gelatin.1 Bioavailability enhancer piperine as BioPerine® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585.