FDA label 498f5516-b5cd-0606-e063-6294a90a4577

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)

SPL set ID
fc605a43-617a-455a-841e-e61ceeb21778
SPL ID
498f5516-b5cd-0606-e063-6294a90a4577
Version
2
Effective date
2026-01-29
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:51

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS AND PRECAUTIONS KEEP OUT OF THE REACH OF CHILDREN. In case of an accidental overdose, call a doctor or a poison control center immediately. Tell your doctor if you have: kidney problems or thyroid disease. This medication should be used as directed by your physician during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Call your doctor if you experience any of the following rare but possible signs of hypervitaminosis D: nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, mental/mood changes or unusual tiredness. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Solutech Pharmaceuticals LLC, at 1-877-829-3135

Reported adverse events (FAERS/openFDA)#

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