Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from heat, light and moisture. (Tamper Evident: Do not use if seal is broken or missing.) JAYMAC Pharmaceuticals, LLC, 2085 I-49 S. Service Rd, Sunset, LA 70584 MANUFACTURED AND/OR PACKAGED IN USA/CANADA Rev April 10, 2024 (V17)
ENLTMis a medical food for use under medical supervision to assist patients with MTHFR polymorphisms and other B-vitamin polymorphisms or “IEMs” in the clinical dietary management of depression or ADHD. It is specially formulated to meet the distinctive nutritional requirements of these patients and may be used alone or as an adjunct to standard therapy in the clinical dietary management of these conditions.
Each ENLTM capsule contains 15 mg DFE of reduced folates (from 7mg LevoMeFolic Acid [L-methylfolate Magnesium, CAS# 1429498-11-2] and ~3.5mg Levoleucovorin [Folinic Acid]) plus Adenosylcobalamin.
A recent study+ suggested that EnLyte® 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 Posititive for MTHFR C677T or A1298C Polymorphism.
1 Pure amino acid, cysteinated iron chelate as AminoFerr® under exclusive license by Viva Pharmaceuticals, Canada, U.S. Patent #7341708.
CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.
INDICATION FOR USE:
INDICATIONS & USAGE SECTION
Clinical dietary management of Major Depressive Disorder or Attention-Deficit/Hyperactivity Disorder (ADHD) in patients with distinctive nutritional requirements related to impaired folate metabolism, such as those associated with MTHFR polymorphisms or other inborn errors of metabolism.
ADVERSE REACTIONS:
ADVERSE REACTIONS SECTION
Allergic reactions have been reported following the use of oral folate. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with Vitamin B12.
PRECAUTIONS:
PRECAUTIONS SECTION
Folinic acid, when administered in daily doses above 0.1 mg, may obscure the detection of B12 deficiency specifically, the administration of folinic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological issues. Folate therapy alone is inadequate for the treatment of a B12 deficiency.
RECOMMENDED USE:
DOSAGE & ADMINISTRATION SECTION
The usual dose is one (1) ENL capsule given daily with or without food, or as directed under medical supervision. No age restrictions.
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:
HOW SUPPLIED SECTION
ENL Bottle of 30 Product Code # 64661-082-25*. Each ENL reddish brown oval softgel is imprinted with “082”.
*JAYMAC does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems.
STORAGE:
STORAGE AND HANDLING SECTION
Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from heat, light and moisture.
(Tamper Evident: Do not use if seal is broken or missing.)
JAYMAC Pharmaceuticals, LLC, 2085 I-49 S. Service Rd, Sunset, LA 70584