NDC | 64661-711-30 |
Set ID | e83b2dd3-a9a0-40bc-ade4-6cd4db433b06 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Jaymac Pharmaceuticals LLC |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
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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.
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INACTIVE INGREDIENT
OTHER INGREDIENTS: 25 mg ascorbates4 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate), 500 mcg betaine (trimethylglycine), 13.6 mg FeGC3 (1.5 mg elemental iron from ferrous glycine cysteinate), 25 mcg flavin adenine dinucleotide (reduced vitamin B2), 1 mg magnesium l-threonate, 25 mcg nicotinamide adenine dinucleotide hydride (reduced vitamin B3), at least 19.2 mg phospholipid-omega complex5, 25 mcg pyridoxal 5’ phosphate (reduced vitamin B6), 25 mcg thiamine pyrophosphate (reduced vitamin B1).
EXCIPIENTS: Annatto [colorant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates), gelatin (bovine), glycerine, piperine, plant lipids (sunflower), purified water, ubidecarenone, yellow beeswax.
1 Coenzyme B12 is the primary form most found in mammalian liver
2 Derived from folinic acid - a provitamer of B12 cofactor, l-methylfolate
3 Pure amino acid, cysteinated iron chelate as AminoFerTM under exclusive license
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:
- MECHANISM OF ACTION:
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BOXED WARNING
(What is this?)
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 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.
- ADVERSE REACTIONS:
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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 3 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. A 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.
- DOSAGE AND ADMINISTRATION:
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label
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INGREDIENTS AND APPEARANCE
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 capsule, delayed release pelletsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64661-711 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN 2.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 7 mg FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CYSTEINE GLYCINATE 13.6 mg 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 6WJM73T46K) (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:DVY07ILF1W) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (UNII: 9ABD9DRK7B) (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE - UNII:C3019D8IIA) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug PHOSPHATIDYL SERINE (UNII: 394XK0IH40) (PHOSPHATIDYL SERINE - UNII:394XK0IH40) PHOSPHATIDYL SERINE 12 mg PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug FLAVIN ADENINE DINUCLEOTIDE (UNII: ZC44YTI8KK) (FLAVIN ADENINE DINUCLEOTIDE - UNII:ZC44YTI8KK) FLAVIN ADENINE DINUCLEOTIDE 25 ug NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 25 ug COBAMAMIDE (UNII: F0R1QK73KB) (COBAMAMIDE - UNII:F0R1QK73KB) COBAMAMIDE 50 ug COCARBOXYLASE (UNII: Q57971654Y) (COCARBOXYLASE - UNII:Q57971654Y) COCARBOXYLASE 25 ug MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE 24 mg ZINC ASCORBATE (UNII: 9TI35313XW) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ZINC ASCORBATE 1 mg MAGNESIUM L-THREONATE (UNII: 1Y26ZZ0OTM) (THREONIC ACID, L- - UNII:75B0PMW2JF) MAGNESIUM L-THREONATE 1 mg BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE 500 ug CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1.83 mg SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE 3.67 mg Inactive Ingredients Ingredient Name Strength ANNATTO (UNII: 6PQP1V1B6O) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) OLIVE OIL (UNII: 6UYK2W1W1E) PIPERINE (UNII: U71XL721QK) WATER (UNII: 059QF0KO0R) UBIDECARENONE (UNII: EJ27X76M46) YELLOW WAX (UNII: 2ZA36H0S2V) Product Characteristics Color BROWN (annatto) Score no score Shape OVAL Size 14mm Flavor ORANGE (creamy orange) Imprint Code ENL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64661-711-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/12/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/12/2011 Labeler - Jaymac Pharmaceuticals LLC (830767260) Registrant - Jaymac Pharmaceuticals LLC (830767260) Establishment Name Address ID/FEI Business Operations Viva Pharmaceuticals INC 253288898 manufacture(64661-711)