PaxLyte

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
PaxLyte
Generic name
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
Manufacturer
Jaymac Pharmaceuticals
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
f520b130-61b3-443e-aaf6-91e094e7a334
SPL ID
27a4406e-5cdf-46d7-bb01-38806ae851cb
Version
5
Effective date
2025-12-08
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:14:44
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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warnings and cautions

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.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS 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 .

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.