Azelastine HCl AZELASTINE AMNEAL PHARMACEUTICALS NY LLC FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
FunFoxMeds box
Route
NASAL
Applications
ANDA216576
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each spray) Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)
Inactive Ingredients
Inactive ingredients benzalkonium chloride edetate disodium hypromellose purified water sodium citrate sorbitol and sucralose
Strengths
205.5 mcg 187.6 mcg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Nasal Congestion Runny Nose Sneezing Itchy Nose
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0365162706840
UNII
0L591QR10I
Packaging

Principal Display Panel Label Carton

Package Descriptions
  • Principal Display Panel Label Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions Read the User Guide for how to: prime the bottle before first use use the spray prime bottle again if not used for 3 or more days clean the spray nozzle if it gets clogged adults and children 12 years and older This product may be used either once or twice a day: ■ once daily : use 2 sprays in each nostril; OR ■ twice daily : use 1 or 2 sprays in each nostril every 12 hours ■ do not use more than 4 sprays in each nostril in a 24 hour period children 6 years to 11 years ■ an adult should supervise use ■ 1 spray in each nostril every 12 hours ■ do not use more than 2 sprays in each nostril in a 24 hour period children under 6 years do not use

Warnings & Precautions
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 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 motor vehicle or operation 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 (1-800-222-1222).
Purpose

Purpose Antihistamine

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving motor vehicle or operation 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 & Ask a Doctor

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

Keep Out of Reach of Children

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).

Questions

Questions or Comments? Call 1-877-835-5472 (Mon-Fri, 9AM-5PM EST) Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2021-00


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