PAI, Hydroxyzine HCl Oral Solution

Hydroxyzine HCl Oral Solution by

Drug Labeling and Warnings

Hydroxyzine HCl Oral Solution by is a Prescription medication manufactured, distributed, or labeled by TriRx Hunsville Pharmaceutical Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYDROXYZINE HCL ORAL SOLUTION- hydroxyzine hcl oral solution liquid 
TriRx Hunsville Pharmaceutical Services

----------

PAI, Hydroxyzine HCl Oral Solution

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Geriatric Use

Adverse Reactions I

Adverse Reactions II

Adverse Reactions III

Overdosage

Dosage and Administration

How Supplied

HYDROXYZINE HCL ORAL SOLUTION 
hydroxyzine hcl oral solution liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-059
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYZINE DIHYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)	HYDROXYZINE DIHYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-059-33	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040391	12/09/2024

Labeler - TriRx Hunsville Pharmaceutical Services (117090286)

Revised: 12/2024

Document Id: 28d8eb85-0847-a56b-e063-6294a90acec8

34391-3

Set id: 28d8eb85-0846-a56b-e063-6294a90acec8

Version: 1

Effective Time: 20241209