FDA.reportPublic FDA data

Hydroxyzine HCl Oral Solution

Manufacturer
TriRx Hunsville Pharmaceutical Services
Effective date
2024-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:47:10

Label at a glance#

ProductHydroxyzine HCl Oral Solution
Active ingredientHYDROXYZINE DIHYDROCHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

DescriptionDescription

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Clinical PharmacologyClinical Pharmacology

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Contraindications

CONTRAINDICATIONS SECTION

ContraindicationsContraindications

Warnings

WARNINGS SECTION

WarningsWarnings

Precautions

PRECAUTIONS SECTION

PrecautionsPrecautions

Geriatric Use

GERIATRIC USE SECTION

Geriatric UseGeriatric Use

Adverse Reactions I

ADVERSE REACTIONS SECTION

Adverse Reactions IAdverse Reactions I

Adverse Reactions II

ADVERSE REACTIONS SECTION

Adverse Reactions IIAdverse Reactions II

Adverse Reactions III

ADVERSE REACTIONS SECTION

Adverse Reactions IIIAdverse Reactions III

Overdosage

OVERDOSAGE SECTION

OverdosageOverdosage

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

How Supplied

HOW SUPPLIED SECTION

How SuppliedHow Supplied

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80432-05980432-059-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDROXYZINE DIHYDROCHLORIDE76755771U3ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCROSEC151H8M554IACT
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28d8eb85-0847-a56b-e063-6294a90acec828d8eb85-0846-a56b-e063-6294a90acec82024-12-09Warnings, Adverse reactionsExact identifier
spl id: 28d8eb85-0847-a56b-e063-6294a90acec8
spl set id: 28d8eb85-0846-a56b-e063-6294a90acec8

Reported adverse events (FAERS/openFDA)#

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