RVP

Drug Catalog - Product Detail

CETIRIZINE RX SYRUP LIQ 1MG/ML 470ML

NDC Mfr Size Str Form
54838-0572-80 SILARX 473 1MG/ML SOLUTION
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2-[4-[(4-chlorophenyl)phenylmethyl] -1-piperazinyl] ethoxy] acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the syrup are: Cetirizine Hydrochloride Oral Solution, USP - Fruity Flavor: calcium acetate; fruity flavor; glacial acetic acid; glycerin; methylparaben; propylene glycol; propylparaben; and water. Cetirizine Hydrochloride Oral Solution, USP - Grape Flavor: calcium acetate; glacial acetic acid; glycerin; grape flavor; methylparaben; propylene glycol; propylparaben; and water. molec-struc
How Supplied
HOW SUPPLIED Cetirizine Hydrochloride Oral Solution, USP is colorless to slightly yellow and available in fruity or grape flavor. Each teaspoon (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP is supplied as follows: NDC 54838-571-40 (Fruity Flavor) 120 mL bottles NDC 54838-571-80 (Fruity Flavor) 473 mL bottles NDC 54838-572-40 (Grape Flavor) 120 mL bottles NDC 54838-572-80 (Grape Flavor) 473 mL bottles STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 10-1113 Rev. 02/20
Indications & 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Cetirizine hydrochloride oral solution can be taken without regard to food consumption. Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of cetirizine hydrochloride oral solution in children aged 2 to 5 years is 2.5 mg (½ teaspoon) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or ½ teaspoonful syrup given every 12 hours. Children 6 months to <2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of cetirizine hydrochloride oral solution in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.