FDA label 4d9d861f-f48e-4c59-b6e8-22756387fb5d

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
0f71b078-a957-47ed-a235-922c27c9a621
SPL ID
4d9d861f-f48e-4c59-b6e8-22756387fb5d
Version
2
Effective date
2016-01-01
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:08

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

ADVERSE REACTIONS Side effects reported with the administration of hydrOXYzine hydrochloride are usually mild and transitory in nature. Dry mouth. Anticholinergic: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Central Nervous System: In post-marketing experience, the following additional undesirable effects have been reported: Allergic reaction. Body as a Whole: Headache. Nervous System: Hallucination. Psychiatric: Oral hydroxyzine hydrochloride is associated with fixed drug eruptions in postmarketing reports. Skin and Appendages:

Reported adverse events (FAERS/openFDA)#

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