Cetirizine Hydrochloride Tablets

FDA Drug Profile — Cetirizine Hydrochloride, cetirizine hydrochloride

Drug Details

Generic Name
Cetirizine Hydrochloride Tablets
Brand Names
Cetirizine Hydrochloride, cetirizine hydrochloride
Application Number
ANDA078343
Sponsor
Preferred Pharmaceuticals Inc.
NDC Codes
9
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
CETIRIZINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat .

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: If breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.