RVP

Drug Catalog - Product Detail

CETIRIZINE RX SYRUP LIQ 1MG/ML 120ML

NDC Mfr Size Str Form
51991-0837-04 BRECKENRIDGE 120 1MG/ML NA
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Generic Name
CETIRIZINE HYDROCHLORIDE
Substance Name
CETIRIZINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078488
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
How Supplied
HOW SUPPLIED Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, is colorless to slightly yellow with a banana-grape flavor. Each teaspoonful (5 mL) contains 5 mg cetirizine hydrochloride. Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, is supplied as follows: 120 mL bottle NDC 51991-837-04 480 mL bottle NDC 51991-837-16 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 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, 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 (½ teaspoonful) once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful once a day, or one ½ teaspoonful 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 (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.