boxed warning
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
FDA label f22389d3-ea5a-46bb-8a26-852a7080e56f
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
- f74db588-313c-4eec-8c9d-9ff9455c9fa6
- SPL ID
- f22389d3-ea5a-46bb-8a26-852a7080e56f
- Version
- 1000
- Effective date
- 2014-07-17
- 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 05:58:57
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 | f22389d3-ea5a-46bb-8a26-852a7080e56f | id | |
| spl set id | f74db588-313c-4eec-8c9d-9ff9455c9fa6 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
boxed warning
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of reach of children. In case of accidental overdose, call a physician or Poison Control Center immediately.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.