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 · Capsule · Oral
Uses
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.
Dosage and administration
The normal dose, is one capsule daily OR as directed by a licensed healthcare practioner; preferably on an empty stomach.
Warnings and 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.
Side effects
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
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.
Mechanism of action
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.
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.
Label text from the FDA structured product label by Jaymac Pharmaceuticals (revised Dec 8, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Leucovorin in 1 product
- Folic Acid in 1 product
- Levomefolate Magnesium in 1 product
- Ferrous Cysteine Glycinate in 1 product
- 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium in 1 product
- 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium in 1 product
- Phosphatidyl Serine in 1 product
- Pyridoxal Phosphate Anhydrous in 1 product
- Flavin Adenine Dinucleotide in 1 product
- Nadh in 1 product
- Cobamamide in 1 product
- Cocarboxylase in 1 product
PaxLyte NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 64661-217 | Leucovorin 2.5 mg/1; Folic Acid 1 mg/1; Levomefolate Magnesium 7 mg/1; Ferrous Cysteine Glycinate 13.6 mg/1;… Capsule | Jaymac Pharmaceuticals | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is PaxLyte used for?
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.
What are the side effects of PaxLyte?
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 . See the full label for the complete list.
Who makes PaxLyte?
PaxLyte is listed by 1 labeler in the FDA NDC directory, including Jaymac Pharmaceuticals.