Generic Name: folate supplement
Dosage Form: capsule, delayed release pellets
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.
[50 mcg B12] [2.5 mg F-THf, 1mg PteGlu, 7mg Me-THf]
ANTI-PERNICIOUS ANEMIA B12-PREPARATION with B12-cofactor levomefolic acid, magnesium salt.
Prescription Hematinic Drug For Therapeutic Use
Softgel Capsules (30ct bottle)
Rx Only [DRUG]
EnLyte® is an orally administered prescription hematinic drugfor therapeutic use formulated for adult macrocytic anemia patients ages 12 and up, who are under specific direction and monitoring of vitamin B12 status by a physician
|Adenosylcobalamin (coenzyme B12)||50 mcg|
|Formyltetrahydrofolic acid (B9-vitamer)||2.5 mg*|
|Folic acid, DHF - (provitamin B9)||1 mg*|
|Levomefolic acid, magnesium salt (B12 cofactor)||7 mg†|
FUNCTIONAL EXCIPIENTS: 13.6 mg FeGC as ferrous glycine cysteinate (1.5 mg elemental iron1) [colorant], 25 mg ascorbates1,2 (24 mg magnesium l-ascorbate, 1 mg zinc l-ascorbate) [antioxidant], at least 5.5 mg citrates (at least 1.83 mg citric acid, at least 3.67 mg sodium citrates) [stabilizers], at least 23.33 mg phospholipid-omega3 complex3 [marine lipids], 500 mcg betaine (trimethylgycine) [acidifier], 1 mg magnesium l-threonate [stabilizer].
OTHER EXCIPIENTS: Annatto [colorant], flavin adenine dinucleotide4 (FAD), gelatin (bovine), glycerine, plant lipids (sunflower) [lecithin], natural orange flavor [masking], nicotinamide adenine dinucleotide hydride4 (NADH), pyridoxal 5 phosphate6 (P5P), piperine [bioavailability enhancer], purified water, thiamine pyrophosphate4, ubidecarnone [antioxidant], yellow beeswax.
Certified 3rd-party GLUTEN-FREE. No artificial colorants. No dairy, wheat, sugar or egg.
- 30% daily value (DV) of VITAMIN C, and 10% DV IRON.
- NOT a significant source of magnesium and zinc.
- 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 less than 2% (<25 mcg/each) of vitamins B1, B2, B3 and B6
MECHANISM OF ACTION:
Vitamin B12[active]; Vitamin B9 [prevention]
EnLyte® is indicated in the treatment of pernicious anemia, and the prevention of vitamin B9 deficiency.
Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.
DOSAGE AND ADMINISTRATION:
The adult dose is one capsule daily preferably on an empty stomach.
Do not exceed recommended dose. Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.
Oval, brownish-orange softgel capsule with “ENL” 7 on one side, in bottles of 30 with NDC 64661-711-30.
Store at 20°-25°C (68°-77°F). Protect from light and moisture as contact with moisture may produce surface discoloration and/or erosion.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident:Do not use if seal is broken or missing.
JayMac Pharmaceuticals, LLC; Sunset, LA 70584.
MANUFACTURED AND/OR PACKAGED IN USA/CANADA.
US Patent No 7,935,365; and other patent applications pending.
EnLyte® is a registered mark of JayMac Pharmaceuticals. DeltaFolate™ is a use-trademark of JayMac Pharmaceuticals.
Rev August 2017
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30 MULTIPHASIC SOFTGELS Bottle Label
(2.5mg F-THF, 1mg PteGlu CR, 7mg Me-THF-Mg)
ANTI-PERNICIOUS ANEMIA B12 - PREPARATION
with B12-cofactor levomefolic acid, magnesium salt
SOFTGELS (30ct BOTTLE)
Presciption Hematinic Drug for Therapeutics Use
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
|Labeler - Jaymac Pharmaceuticals LLC (830767260)|
|Registrant - Jaymac Pharmaceuticals LLC (830767260)|
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- Drug class: iron products