FDA label cebec6d3-1451-45f3-a7a8-963f25c85590

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
80ce0a14-bcbe-43a9-83a3-5b82366d078a
SPL ID
cebec6d3-1451-45f3-a7a8-963f25c85590
Version
4
Effective date
2024-10-04
Source export date
2026-11-06
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/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:04:36

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Do not give to children under 12 years of age unless directed by a doctor

warnings table

<table border="0" width="100%"><tbody><tr><td><paragraph><content styleCode="bold">Warnings </content> </paragraph><paragraph>Do not give to children under 12 years of age unless directed by a doctor</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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