FDA label cd92bf2d-3d1e-4b37-90c6-a554916eee3c
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
- 968c74e0-0510-4a0e-add2-37af97fc6928
- SPL ID
- cd92bf2d-3d1e-4b37-90c6-a554916eee3c
- Version
- 6
- Effective date
- 2018-04-17
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:35:00
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 | cd92bf2d-3d1e-4b37-90c6-a554916eee3c | id | |
| spl set id | 968c74e0-0510-4a0e-add2-37af97fc6928 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep these products out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS: Keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses. Pediatric Use: Safety and effectiveness in pediatric patients has 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.