AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AUROHEALTH 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 bottle
Route
NASAL
Applications
ANDA216561

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each spray) Azelastine hydrochloride USP 205.5 mcg (equivalent to 187.6 mcg azelastine)
Inactive Ingredients
Inactive ingredients benzalkonium chloride edetate disodium hypromellose purified water sodium citrate (dihydrate) sorbitol and sucralose. Questions or comments? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor NJ 08520 Made in India Code: AP/DRUGS/04/2016
Strengths
205.5 mcg 187.6 mcg
Quantities
11 ml 30 ml
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 BOTTLE
UNII
0L591QR10I
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (11 mL Bottle) AUROHEALTH NDC 58602-020-51 Azelastine Hydrochloride Nasal Spray 205.5 mcg per spray ANTIHISTAMINE NASAL SPRAY ALLERGY + CONGESTION 60 METERED SPRAYS 0.37 fl oz (11 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (30 mL Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (11 mL Bottle) AUROHEALTH NDC 58602-020-51 *Compare to the active ingredient in ASTEPRO ® ALLERGY Azelastine Hydrochloride Nasal Spray 205.5 mcg per spray ANTIHISTAMINE NASAL SPRAY ALLERGY + CONGESTION FULL PRESCRIPTION STRENGTH STEROID FREE Alcohol-Free Fragrance-Free UP TO 24 HOUR RELIEF OF • Nasal congestion • Runny nose • Sneezing • Itchy nose 60 METERED SPRAYS 0.37 fl oz (11 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (30 mL Bottle)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (11 mL Bottle) AUROHEALTH NDC 58602-020-51 Azelastine Hydrochloride Nasal Spray 205.5 mcg per spray ANTIHISTAMINE NASAL SPRAY ALLERGY + CONGESTION 60 METERED SPRAYS 0.37 fl oz (11 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (30 mL Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (11 mL Bottle) AUROHEALTH NDC 58602-020-51 *Compare to the active ingredient in ASTEPRO ® ALLERGY Azelastine Hydrochloride Nasal Spray 205.5 mcg per spray ANTIHISTAMINE NASAL SPRAY ALLERGY + CONGESTION FULL PRESCRIPTION STRENGTH STEROID FREE Alcohol-Free Fragrance-Free UP TO 24 HOUR RELIEF OF • Nasal congestion • Runny nose • Sneezing • Itchy nose 60 METERED SPRAYS 0.37 fl oz (11 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (30 mL Bottle)

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.
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 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 & 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 (1-800-222-1222) right away.

Storage & Handling

Other information store between 20° to 25°C (68° to 77°F). Protect from freezing. keep this carton and the enclosed User Guide for important information do not use if seal printed with “sealed for your protection” on top and bottom carton flaps is not intact.


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