FDA label 451b5247-4660-9ebe-e063-6294a90a13c2

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
d55dfce1-acef-3342-e053-2a95a90a4b83
SPL ID
451b5247-4660-9ebe-e063-6294a90a13c2
Version
5
Effective date
2025-12-04
Source export date
2026-11-06
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:49:45

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

DO NOT USE if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Reported adverse events (FAERS/openFDA)#

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