FDA label ce6d560c-49f6-4a85-bf9b-a816db6d3c8d

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
004c3ee5-8f32-4ebb-923b-e867b2976c2a
SPL ID
ce6d560c-49f6-4a85-bf9b-a816db6d3c8d
Version
2
Effective date
2019-09-23
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:45

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

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 Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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