FDA label 1b3e7570-9198-57cc-e063-6394a90a24bd

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: 9e8e7f3f-fa1d-24bf-e053-2a95a90a679b
SPL ID: 1b3e7570-9198-57cc-e063-6394a90a24bd
Version: 5
Effective date: 2024-06-19
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:33

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		1b3e7570-9198-57cc-e063-6394a90a24bd	id
spl set id		9e8e7f3f-fa1d-24bf-e053-2a95a90a679b	set_id

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 a doctor or pharmacists before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Reported adverse events (FAERS/openFDA)#

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