warnings
WARNINGS: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.
FDA label 4b22195d-d683-4ced-ae90-2aa395765bf8
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
- 864fdaeb-a030-4ebd-93f1-a51d4e8eaa94
- SPL ID
- 4b22195d-d683-4ced-ae90-2aa395765bf8
- Version
- 4
- Effective date
- 2009-10-26
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:00:09
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 | 4b22195d-d683-4ced-ae90-2aa395765bf8 | id | |
| spl set id | 864fdaeb-a030-4ebd-93f1-a51d4e8eaa94 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. PEDIATRIC USE: Safety and effectiveness in pediatric patients have not been established. GERIATRIC USE: Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.