{"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 ."],"description":["DESCRIPTION PaxLyte is an orally administered prescription vitamin for therapeutic use formulated for patients who are under specific direction and monitoring of homocysteine (HCY) status by a physician. It is specifically formulated for patients with deficiencies in folate and vitamin B 12 , including those with genetic polymorphisms affecting homocysteine metabolism. A recent study + suggested that PaxLyte was effective in lowering homocysteine 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 Positive for MTHFR C677T or A1298C Polymorphism."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The normal dose, is one capsule daily OR as directed by a licensed healthcare practioner; preferably on an empty stomach."],"effective_time":"20251208","how_supplied":["HOW SUPPLIED PaxLyte is an oval, brownish orange softgel capsule with imprint 7N3 (NDC 64661-217-30*). * This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Due to the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications."],"id":"27a4406e-5cdf-46d7-bb01-38806ae851cb","indications_and_usage":["INDICATION PaxLyte is indicated in the TREATMENT of vitamin deficiency – specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate."],"mechanism_of_action":["MECHANISM OF ACTION VITAMIN B 12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION]; Vitamin B 12 is essential for the synthesis of methionine from homocysteine - a reaction which also requires l-methylfolate as a necessary cofactor."],"openfda":{"brand_name":["PaxLyte"],"generic_name":["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 CAPSULE"],"is_original_packager":[true],"manufacturer_name":["Jaymac Pharmaceuticals"],"nui":["N0000178369","M0008658","N0000175804","N0000175805"],"package_ndc":["64661-217-30"],"pharm_class_cs":["Folic Acid [CS]"],"pharm_class_epc":["Folate Analog [EPC]","Methylating Agent [EPC]"],"pharm_class_moa":["Methylating Activity [MoA]"],"product_ndc":["64661-217"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["27a4406e-5cdf-46d7-bb01-38806ae851cb"],"spl_set_id":["f520b130-61b3-443e-aaf6-91e094e7a334"],"substance_name":["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 PHOSPHATE ANHYDROUS","FLAVIN ADENINE DINUCLEOTIDE","NADH","COBAMAMIDE","COCARBOXYLASE","MAGNESIUM ASCORBATE","ZINC ASCORBATE","MAGNESIUM L-THREONATE","BETAINE","CITRIC ACID MONOHYDRATE","SODIUM CITRATE"],"unii":["Q573I9DVLP","935E97BOY8","1VZZ62R081","8B4OP7RK5N","6WJM73T46K","9ABD9DRK7B","394XK0IH40","F06SGE49M6","ZC44YTI8KK","4J24DQ0916","F0R1QK73KB","Q57971654Y","0N1G678593","9TI35313XW","1Y26ZZ0OTM","3SCV180C9W","2968PHW8QP","1Q73Q2JULR"],"upc":["0364661217307"]},"package_label_principal_display_panel":["image description"],"set_id":"f520b130-61b3-443e-aaf6-91e094e7a334","spl_product_data_elements":["PaxLyte 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 capsule 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 (annatto) 7N3"],"spl_unclassified_section":["CONTAINS Each PaxLyte Softgel Contains: Adenosylcobalamin 1 (vitamin B 12 ) .......................... 50 mcg Folinic Acid (B 9 vitamer).......................................... 4.25 mg DFE (2.5 mg) Folic Acid (B 9 vitamer)............................................ 1.7 mg DFE (1 mg) L-Methylfolate Magnesium (B 9 vitamer)..................... 11.9 mg DFE (7 mg) OTHER INGREDIENTS: Olive oil, gelatin, glycerin, magnesium ascorbate, at least 20 mg Phosphatidylserine DHA Complex (Sharp-PS® Gold) 2 , yellow beeswax, sodium citrate, sunflower lecithin, citric acid, annatto extract, 1.5 mg elemental iron (as ferrous glycine cysteinate) 3 , zinc ascorbate, 1 mg magnesium l-threonate, natural orange flavor, piperine, CoQ10 (ubidecarenone), betaine, 25 mcg flavin adenine dinucleotide (reduced vitamin B 3 ), 25 mcg nicotinamide adenosine dinucleotide hydride (reduced vitamin B 2 ), 25 mcg pyridoxal 5’ phosphate (reduced vitamin B 6 ), 25 mcg thiamine pyrophosphate (reduced vitamin B 1 ). 1 Adenosylcobalamin is an active coenzyme form of Vitamin B 12 found in the human body. 2 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). 3 Pure amino acid, cysteinated iron chelate. CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg. CONTAINS FISH/KRILL/SOY . No artificial colorants. No dairy, wheat, sugar or egg."],"version":"5","warnings_and_cautions":["PRECAUTIONS Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Daily doses of 0.1 mg or more of folic acid (vitamin B 9 ) may obscure pernicious anemia. Hematologic improvement can occur while neurological damage progresses. Exclusive use of folic acid to treat vitamin B 12 -deficient macrocytic anemia can lead to progressive and irreversible neurological damage. Vitamin B 12 deficiency allowed to progress for over 3 months may cause permanent spinal cord lesions. Doses of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B 9 deficiency. Indiscriminate administration may mask the true diagnosis."]}