boxed warning
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
FDA label e3f28512-f778-462f-97b0-78af005dffe3
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
- 70f941bd-40d5-4c25-84ab-7f81344160aa
- SPL ID
- e3f28512-f778-462f-97b0-78af005dffe3
- Version
- 5
- Effective date
- 2016-08-10
- Source export date
- 2026-10-12
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:50:14
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 | e3f28512-f778-462f-97b0-78af005dffe3 | id | |
| spl set id | 70f941bd-40d5-4c25-84ab-7f81344160aa | 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.