FDA label d1c75898-a823-4d94-9d35-38acf6527db5
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
- 578a7991-b26a-4544-9836-d5018eaeff37
- SPL ID
- d1c75898-a823-4d94-9d35-38acf6527db5
- Version
- 2
- Effective date
- 2019-05-28
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:41:35
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 | d1c75898-a823-4d94-9d35-38acf6527db5 | id | |
| spl set id | 578a7991-b26a-4544-9836-d5018eaeff37 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING: Accidental overdose of Iron-containing products is the leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea and constipation) occur occasionally, but are usually mild and may subside with continuation of therapy and physician encouragement. Although the absorption of iron is best taken between meals, giving PureFe Plus after meals may control occasional gastrointestinal disturbances. PureFe Plus is best absorbed when taken at bedtime.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.