BOXED WARNING SECTION.
WARNINGS: 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 examinations and laboratory studies of pernicious anemia patients are essential and recommended. The parental administration of (cyano)cobalamin or vitamin B12, is generally recognized as fully effective treatment of pernicious anemia. Parental alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician. Call your medical practitioner about side effects.You may report side effects by calling 337.662-5962.KEEP THIS OUT OF THE REACH OF CHILDREN.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label NDC 64661-711-30 Rx Only EnLyte with DeltaFolateTM (2.5 mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg [50 mcg CBI][1.5 mg FeGC] ANTI-ANEMIA PREPARATION as folate, cobalamin & iron Certified 3rd-party GLUTEN-FREE JAYMAC Pharmaceuticals, LLC SOFTGELS (30ct BOTTLE) Presciption Folate/Hematinic Drug For Therapeutic Use
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of cobalamin. Allergic sensitization has been reported following both oral and parenteral administration of folate.
INDICATIONS & USAGE SECTION.
INDICATIONS: EnLyte is indicated in the treatment of folate-induced macrocytic anemias including megaloblastic anemias, resulting from deficiency - including megaloblastic anemias, and the prevention of cobalamin deficiency. EnLyte is indicated in the maintenance of normal hematologic status (hematopoiesis) as well as supplement for other folate and cobalamin deficiencies.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: The adult dose is one capsule daily preferably on an empty stomach. Call your medical practitioner about side effects.You may report side effects by calling 337.662-5962.KEEP THIS OUT OF THE REACH OF CHILDREN. Do not exceed the recommended dose.
SPL UNCLASSIFIED SECTION.
EnLyte with DeltaFolate [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf][50 mcg CBI][1.5 mg FeGC] ANTI-ANEMIA PREPARATION as folate, cobalamin & iron Certified 3rd-party GLUTEN-FREE JAYMAC Pharmaceuticals, LLC Softgels (30ct bottle) Prescription Folate/Hematinic Drug For Therapeutic Use
HOW SUPPLIED SECTION.
HOW SUPPLIED: Oval, brownish-orange softgel capsule with ENL 7 on one side, in bottles of 30 with NDC 64661-711-30.
Description EnLyte is an orally administered prescription folate/hematinic drug for therapeutic use formulated for adult macrocytic anemia patients - ages 12 and up, who are under specific direction and monitoring of folate, cobalamin and iron status by a physician. EnLyte, through passive diffusion of folate-vitamers, is intended to address the increased need for metabolically-active forms of folate in the cerebrospinal fluid, plasma, and/or red blood cells in patients with MTHFR (at alleles C667T, A1298C and/or G1793A) and/or macrocytic anemia. EnLyte may be useful in patients at risk of depression due to a deficiency of folate and/or cobalamin. EnLyte may be taken by women of childbearing age. EnLyte may be taken by geriatric patients where compliance is an issue.
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 folic acid (in preparations) is 1 mg [emphasis added].
STORAGE AND HANDLING SECTION.
STORAGE: STORAGE: Store at 20-25 C (68-77 F) (Tamper Evident: Do not use if seal is broken or missing.) JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584 MANUFACTURED AND/OR PACKAGED IN USA/CANADA Rev April 2019
INACTIVE INGREDIENT SECTION.
FUNCTIONAL EXCIPIENTS: 25 mg ascorbates 5,6 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates) [stabilizers], at least 23.33 mg phospholipid-omega complex7 [marine lipids], 500 mcg betaine (trimethylglycine) [acidifier], 1 mg magnesium l-threonate [stabilizer] OTHER EXCIPIENTS: "Annatto color" (as a blend of annatto with stomach substance [thickener/stabilizer]) [colorant], flavin adenine dinucleotide 8 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], nicotinamide adenine dinucleotide hydride 8 (NADH), pyridoxal 5 phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate 8, ubidecarenone [antioxidant], yellow beeswax. 5 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics 6 NOT a significant source of magnesium and zinc. 7 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) 8 Contains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6. CONTAINS FISH/KRILL/SOY. Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.