cetirizine hcl

FDA Drug Profile — Medline, Dye Free Childrens Cetirizine Hydrocholride

cetirizine hcl is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Medline, Dye Free Childrens Cetirizine Hydrocholride. Available dosage forms: tablet, solution.

Drug Details

Generic Name
cetirizine hcl
Brand Names
Medline, Dye Free Childrens Cetirizine Hydrocholride
Application Number
ANDA209274
Sponsor
Medline Industries, LP
NDC Codes
2
Dosage Forms
TABLET, SOLUTION
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. (1-800-222-1222)