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 (canonical bytes are SHA-256 checked before publication)

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
2026-08-08
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/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:24:38

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Boxed warning sections page 1 of 1 · 2 matching rows.

boxed warning

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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 sections page 1 of 1 · 1 matching rows.

warnings

Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.