Cetirizine Hydrochloride Oral Solution

FDA Drug Profile — Cetirizine Hydrochloride Oral Solution

Drug Details

Generic Name
Cetirizine Hydrochloride Oral Solution
Brand Names
Cetirizine Hydrochloride Oral Solution
Application Number
ANDA078870
Sponsor
Preferred Pharmaceuticals Inc.
NDC Codes
3
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
CETIRIZINE HYDROCHLORIDE

Indications and Usage

INDICATIONS AND USAGE Perennial Allergic Rhinitis: Cetirizine hydrochloride oral solution is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine hydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.