ADVERSE REACTIONS SECTION.
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 following both oral and parenteral administration of vitamin B9.
BOXED WARNING SECTION.
WARNINGS:. Caution: This product is not suitable for the TREATMENT of vitamin B12 deficiency secondary to either pernicious anemia and/or gastrointestinal malabsorption (i.e., exocrine pancreatic insufficiency).Caution: The use of vitamin B12 for the TREATMENT of anemnia without direct supervision of physician may be dangerous.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.. Caution: This product is not suitable for the TREATMENT of vitamin B12 deficiency secondary to either pernicious anemia and/or gastrointestinal malabsorption (i.e., exocrine pancreatic insufficiency).. Caution: The use of vitamin B12 for the TREATMENT of anemnia without direct supervision of physician may be dangerous.
Description. EnLyte(R) is an orally administered prescription vitamin for therapeutic use formulated for adult patients ages 12 and up, who are under specific direction and monitoring of homocysteine (HCY) status by physician. recent study+ suggested that EnLyte(R) was effective in lowering homocystine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism). +ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism.
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.
HOW SUPPLIED SECTION.
HOW SUPPLIED:. Oval, brownish-orange softgel capsule with imprint ENL.
INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS: Annatto [colorant], 500 mcg betaine (trimethylglycine), at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates), 25 mcg flavin adenine dinucleotide (reduced vitamin B2), gelatin (bovine), glycerine, mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride (reduced vitamin B3), piperine, plant lipids (sunflower), purified water, 25 mcg pyridoxal phosphate (reduced vitamin B6), 25 mcg thiamine pyrophosphate (reduced vitamin B1), ubidecarenone, yellow beeswax. 1Coenzyme B12 is the primary form most found in mammalian liver. 2Vitamer of B12 cofactor, l-methylfolate. 3Pure amino acid, cysteinated iron chelate. 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics. 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).CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.
INDICATIONS & USAGE SECTION.
INDICATIONS:. EnLyte(R) is indicated in the TREATMENT of vitamin deficiency specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate. Also contains small amount of SUPPLEMENTATION in the form of iron and other folates along with vitamin and phospholipids.
MECHANISM OF ACTION SECTION.
MECHANISM OF ACTION:. VITAMIN B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION];.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30 SOFTGELS Bottle Label. Enlyte-Label image.
PRECAUTIONS:. 0.1 mg or more of vitamin B9 daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. Exclusive use of vitamin B9 in treating vitamin B12-deficient macrocytic anemia could result in progressive and irreversible neurological damage. Specifically, vitamin B12 deficiency allowed to progress over months may produce permanent degenerative lesions of the spinal cord as observed when vitamin B9 therapy is used as the only hematopoietic agent. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B9 deficiency. Indiscriminate administration may mask the true diagnosis. dietary deficiency of only vitamin B12 is rare; multiple vitamin deficiency is expected in any dietary deficiency. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy.
SPL UNCLASSIFIED SECTION.
EnLyte(R)with DeltaFolate(TM)[50 mg CBl] [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]JAYMAC Pharmaceuticals, LLCSoftgels (30ct bottle)Prescription Vitamin For Therapeutic Use.
STORAGE AND HANDLING SECTION.
STORAGE:. STORAGE: Store at 20-25 (68-77 F)(Tamper Evident: Do not use if seal is broken or missing.)JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584MANUFACTURED AND/OR PACKAGED IN USA/CANADARev Dec 27 2021.