FDA.reportPublic FDA data

FDA label c543495d-293e-4bad-b452-339f7997a7ef

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
4db2b4e6-bf5b-4563-adbb-d380184936f4
SPL ID
c543495d-293e-4bad-b452-339f7997a7ef
Version
2
Effective date
2015-02-04
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:06:17

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 product 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 doctor or poison control center immediately.

Adverse reactions cross-check#

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

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

adverse reactions

Call your doctor for medical advise about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Cypress Pharmaceutical, Inc. Madison, MS 39110 L353 Rev. 11/08

Reported adverse events (FAERS/openFDA)#

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