FDA.reportPublic FDA data

FDA label db4d428a-49de-340c-e053-2a95a90a3d6f

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
218eecd3-70a9-4496-8f01-9d7b7897b251
SPL ID
db4d428a-49de-340c-e053-2a95a90a3d6f
Version
3
Effective date
2022-03-24
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:51

Boxed warning cross-check#

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

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

boxed warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdosage, call a doctor or a 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

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately. Tablets should be chewed or crushed before they are swallowed. This product is not recommended for children under age 4 due to risk of choking.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. To report adverse side effects or to obtain product information, contact GM Pharmaceuticals at 1-888-535-0305.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.