Azelastine HCl

FDA Drug Profile — Astepro Allergy, Children Astepro Allergy

Drug Details

Generic Name
Azelastine HCl
Brand Names
Astepro Allergy, Children Astepro Allergy
Application Number
NDA213872
Sponsor
DARMERICA, LLC
NDC Codes
4
Dosage Forms
POWDER, SPRAY, METERED
Routes
NASAL
Active Ingredients
AZELASTINE HYDROCHLORIDE

Indications and Usage

Uses Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

Warnings

Warnings Only for use in the nose. Do not spray in eyes or mouth. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed 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 you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds If pregnant or breast-feeding, 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.