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 examination and laboratory studies of pernicious anemia patients are essential and recommended. The parenteral administration of (cyano)cobalamin or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral alkyl-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label NDC 64661-711-30Rx EnLyte with DeltaFolateTM (2.5 mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg) ANTI-PERNICIOUS ANEMIA B12 - PREPARATION with B12-cofactor levomefolic acid, magnesium salt JAYMAC Pharmaceuticals, LLC SOFTGELS (30ct BOTTLE) Presciption Hematinic Drug for Therapeutics Use
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.
INDICATIONS & USAGE SECTION.
INDICATIONS: EnLyte is indicated in the treatment of pernicious anemia, and the prevention of vitamin B9 deficiency.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: The adult dose is one capsule daily preferably on an empty stomach. Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.
SPL UNCLASSIFIED SECTION.
MECHANISM OF ACTION: Vitamin B12 [active] ; Vitamin B9 [prevention]
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 hematinic drug for therapeutic use formulated for adult macrocytic anemia patients ages 12 and up, who are under specific direction and monitoring of vitamin B12 status by a physician Ingredients Adenosylcobalamin (coenzyme B12) 50 mcg Formyltetrahydrofolic acid (B9-vitamer) 2.5 mg6 mg DFE folate (vitamin B9) of at least 15 mg DFE total folate Folic acid, DHF - (provitamin B9) 1 mg* Levomefolic acid, magnesium salt (B12 cofactor) 7 mgFrom 9 mg l-methylfolate (molar equivalent)
STORAGE AND HANDLING SECTION.
STORAGE: Store at 20-25C (68-77F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion. 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 PACKAGED IN USA/CANADA. PATENTS: US Patent No 7,935,365; and other patent applications pending. TRADEMARKS: EnLyte is a registered mark of JayMac Pharmaceuticals. DeltaFolate is a use-trademark of JayMac Pharmaceuticals. Rev August 2017
INACTIVE INGREDIENT SECTION.
FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron30% daily value (DV) of VITAMIN C, and 10% DV IRON. ) [colorant], 25 mg ascorbates1, NOT a significant source of magnesium and zinc. (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-omega3 complexContains 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) [marine lipids], 500 mcg betaine (trimethylgycine) [acidifier], 1 mg magnesium l-threonate [stabilizer]. OTHER EXCIPIENTS: Annatto [colorant], flavin adenine dinucleotideContains less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride4 (NADH), pyridoxal 5 phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, ubidecarnone [antioxidant], yellow beeswax. CONTAINS FISH/KRILL/SOY. Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.