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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 498f5516-b5cd-0606-e063-6294a90a4577 | id | |
| spl set id | fc605a43-617a-455a-841e-e61ceeb21778 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.