{"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 vitamin B 9 ."],"boxed_warning":["WARNINGS: Caution: This product is not suitable for the TREATMENT of vitamin B 12 deficiency secondary to either pernicious anemia and/or gastrointestinal malabsorption (i.e., exocrine pancreatic insufficiency). Caution: The use of vitamin B 12 for the TREATMENT of anemnia without direct supervision of a 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."],"boxed_warning_table":["
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 a physician may be dangerous.
"],"description":["​Description EnLyte® 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 a physician. A recent study + suggested that EnLyte ® 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 B Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism."],"dosage_and_administration":["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."],"effective_time":"20220701","how_supplied":["HOW SUPPLIED: Oval, brownish-orange softgel capsule with imprint ENL ."],"id":"eff3383d-a004-4293-b3b9-c10ccb016d23","inactive_ingredient":["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 B 2 ), gelatin (bovine), glycerine, 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride (reduced vitamin B 3 ), piperine, plant lipids (sunflower), purified water, 25 mcg pyridoxal 5’ phosphate (reduced vitamin B 6 ), 25 mcg thiamine pyrophosphate (reduced vitamin B 1 ), ubidecarenone, yellow beeswax. 1 Coenzyme B 12 is the primary form most found in mammalian liver. 2 Vitamer of B 12 cofactor, l-methylfolate. 3 Pure amino acid, cysteinated iron chelate. 4 30% daily value (DV) of VITAMIN C, and 10% DV IRON for geriatrics. 5 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_and_usage":["INDICATIONS: EnLyte® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate. Also contains a small amount of SUPPLEMENTATION in the form of iron and other folates along with vitamin C and phospholipids."],"mechanism_of_action":["MECHANISM OF ACTION: VITAMIN B 12 [ TREATMENT ]; FOLATE [ PREVENTION ]; OTHER [ SUPPLEMENTATION ];"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 SOFTGELS Bottle Label Enlyte-Label image"],"precautions":["​PRECAUTIONS: 0.1 mg or more of vitamin B 9 daily may obscure pernicious anemia in that the hematological remission may occur while neurological manifestations remain progressive. Exclusive use of vitamin B 9 in treating vitamin B 12 -deficient macrocytic anemia could result in progressive and irreversible neurological damage. Specifically, vitamin B 12 deficiency allowed to progress over 3 months may produce permanent degenerative lesions of the spinal cord - as observed when vitamin B 9 therapy is used as the only hematopoietic agent. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B 9 deficiency. Indiscriminate administration may mask the true diagnosis. A dietary deficiency of only vitamin B 12 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."],"set_id":"e83b2dd3-a9a0-40bc-ade4-6cd4db433b06","spl_product_data_elements":["EnLyte leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine LEUCOVORIN LEUCOVORIN FOLIC ACID FOLIC ACID LEVOMEFOLATE MAGNESIUM LEVOMEFOLIC ACID FERROUS CYSTEINE GLYCINATE FERROUS CATION 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE PHOSPHATIDYL SERINE PHOSPHATIDYL SERINE PYRIDOXAL PHOSPHATE ANHYDROUS PYRIDOXAL PHOSPHATE ANHYDROUS FLAVIN ADENINE DINUCLEOTIDE FLAVIN ADENINE DINUCLEOTIDE NADH NADH COBAMAMIDE COBAMAMIDE COCARBOXYLASE COCARBOXYLASE MAGNESIUM ASCORBATE ASCORBIC ACID ZINC ASCORBATE ASCORBIC ACID MAGNESIUM L-THREONATE THREONIC ACID, L- BETAINE BETAINE CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID SODIUM CITRATE SODIUM CATION ANNATTO GELATIN GLYCERIN LECITHIN, SUNFLOWER OLIVE OIL PIPERINE WATER UBIDECARENONE YELLOW WAX creamy orange annatto ENL"],"spl_unclassified_section":["EnLyte® with DeltaFolate™ [50 mg CBl] [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf] ​JAYMAC Pharmaceuticals, LLC Softgels (30ct bottle) Prescription Vitamin ​For Therapeutic Use"],"storage_and_handling":["​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 Dec 27 2021"],"version":"13"}