Drug Catalog - Product Detail
CETIRIZINE RX SYRUP SYR 1MG/ML 120ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0626-26 | PADAGIS | 120 | 1MG/ML | SOLUTION |
PACKAGE FILES
Generic Name
CETIRIZINE HYDROCHLORIDE
Substance Name
CETIRIZINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078398
Description
DESCRIPTION Cetirizine hydrochloride is an orally active and selective H 1 -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, USP is a colorless to slightly yellow solution 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 solution are: banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate anhydrous, sucrose, and water. Chemical Structure Image
How Supplied
HOW SUPPLIED Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL is colorless to slightly yellow with a banana-grape flavor. Each 5 mL contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL is available as follows: 120 mL amber plastic bottle (NDC 45802- 626 -26) STORAGE: Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] ; or Store refrigerated, 2°-8°C (36°-46°F).
Indications & Usage
INDICATIONS AND USAGE Perennial Allergic Rhinitis: Cetirizine hydrochloride 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 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, USP 1 mg/mL 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, USP 1 mg/mL in children aged 2 to 5 years is 2.5 mg (2.5 mL) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 5 mL once a day, or 2.5 mL 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, USP 1 mg/mL in children 6 months to 23 months of age is 2.5 mg (2.5 mL) 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 2.5 mL (2.5 mg) every 12 hours.