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EnLyte

Generic name: folate supplement
Dosage form: capsule, delayed release pellets
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

EnLyte®

with DeltaFolate™

[2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]​[50 mcg CBI][1.5 mg FeGC]

​JAYMAC Pharmaceuticals, LLC

Softgels (30ct bottle)

Prescription Vitamin ​For Therapeutic Use

​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.

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:

EnLyte® is indicated in the TREATMENT of vitamin deficiency - specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate.

MECHANISM OF ACTION:

VITAMIN B12 [TREATMENT]; FOLATE [PREVENTION]

WARNINGS:
  1. 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).
  2. 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:

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.

​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:

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:

Oval, brownish-orange softgel capsule with “ENL”7 on one side, in bottles of 30 with NDC 64661-711-30.

​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 Nov 19 2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label

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 pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64661-711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCOVORIN (LEUCOVORIN) LEUCOVORIN 2.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
LEVOMEFOLATE MAGNESIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 7 mg
FERROUS CYSTEINE GLYCINATE (FERROUS CATION) FERROUS CYSTEINE GLYCINATE 13.6 mg
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE) 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM (1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE) 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug
PHOSPHATIDYL SERINE (PHOSPHATIDYL SERINE) PHOSPHATIDYL SERINE 12 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (PYRIDOXAL PHOSPHATE ANHYDROUS) PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug
FLAVIN ADENINE DINUCLEOTIDE (FLAVIN ADENINE DINUCLEOTIDE) FLAVIN ADENINE DINUCLEOTIDE 25 ug
NADH (NADH) NADH 25 ug
COBAMAMIDE (COBAMAMIDE) COBAMAMIDE 50 ug
COCARBOXYLASE (COCARBOXYLASE) COCARBOXYLASE 25 ug
MAGNESIUM ASCORBATE (ASCORBIC ACID) MAGNESIUM ASCORBATE 24 mg
ZINC ASCORBATE (ASCORBIC ACID) ZINC ASCORBATE 1 mg
MAGNESIUM L-THREONATE (THREONIC ACID, L-) MAGNESIUM L-THREONATE 1 mg
BETAINE (BETAINE) BETAINE 500 ug
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 1.83 mg
SODIUM CITRATE (SODIUM CATION) SODIUM CITRATE 3.67 mg
Inactive Ingredients
Ingredient Name Strength
ANNATTO
GELATIN
GLYCERIN
LECITHIN, SUNFLOWER
OLIVE OIL
PIPERINE
WATER
UBIDECARENONE
YELLOW WAX
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
1 NDC:64661-711-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
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 Operations
Viva Pharmaceuticals INC 253288898 manufacture(64661-711)
Jaymac Pharmaceuticals LLC