AZELASTINE HYDROCHLORIDE spray, metered

AZELASTINE HYDROCHLORIDE by

Drug Labeling and Warnings

AZELASTINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each spray)

Azelastine hydrochloride USP 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ nasal congestion ■ runny nose ■ sneezing ■ itchy nose

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

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

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.

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

User Guide

Azelastine Hydrochloride Nasal Spray 205.5 mcg per spray

HOW TO START GETTING STEROID-FREE ALLERGY RELIEF RIGHT NOW

This User Guide will give you detailed directions on how to prime the bottle, use the spray, and how to clean a clogged nozzle.

Keep this User Guide as it contains important information.

GET THE BOTTLE READY

Remove the transparent cap and white clip before using.

PRIME THE BOTTLE

WHEN TO PRIME

• Before you use Azelastine Hydrochloride Nasal Spray for the first time
• If you have not used Azelastine Hydrochloride Nasal Spray for 3 or more days
• After you clean a clogged nozzle

HOW TO PRIME

Aim bottle away from face.

Hold bottle as shown and pump until a fine mist appears.




If a fine mist does not appear after 6 sprays, your nozzle may be clogged. Please see “How to Clean a Clogged Nozzle” section.

HOW TO USE

Important: For use in your nose only

STEP 1

Blow your nose to clear your nostrils.

STEP 2

Tilt your head downward toward your toes.


TILT HEAD DOWNWARD

STEP 3

Hold bottle with thumb under bottle and spray nozzle between fingers.




STEP 4

Close one nostril.





HOLD ONE NOSTRIL SHUT

STEP 5

Put the spray tip about ¼ inch to ½ inch into the other nostril. Hold bottle upright and aim the spray tip toward the back of your nose.

STEP 6

While sniffing gently, press the pump once or twice (according to dosing directions found in Table 1).

Repeat Steps 4, 5 and 6 in other nostril.

STEP 7

Do not tilt your head back immediately after using Azelastine Hydrochloride Nasal Spray. This will help to keep the medicine from going into your throat, which may cause a bitter taste.

STEP 8

When you finish using your Azelastine Hydrochloride Nasal Spray, wipe the spray tip with a clean tissue or cloth. Put the clip and cap back on the bottle.

FOR USE IN CHILDREN

An adult should supervise use.

(See Steps 1 through 8).

SELECT THE DOSE

DIRECTIONS

Do not use more than directed

TABLE 1

• adults & 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

IMPORTANT INFORMATION FOR USE

Remember, 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.

*In clinical trials, drowsiness was observed in less than 4% of patients taking Azelastine Hydrochloride Nasal Spray.

HOW TO CLEAN A CLOGGED NOZZLE

If you cannot get your Azelastine Hydrochloride Nasal Spray to spray a fine mist, the nozzle may be clogged. Don’t try to unclog the nozzle with a pin or sharp object—that can damage it.

• Unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise).

          

• Keep open bottle out of reach of children.
• Fill a bowl or container with warm water. Soak only the spray pump unit in the warm water. Pump the nozzle several times while holding it under the water to clear the clog.

       

• Let the spray pump unit air dry before putting it back on.
• Tightly screw pump unit back on the open bottle by turning clockwise (to the right).
• After cleaning, follow the instructions for priming.

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

Revised: 01/2024

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

           60 METERED SPRAYS
           0.37 fl oz (11 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (11 mL Bottle)

AUROHEALTH

NDC: 58602-020-51
                             *Compare to the active
              ingredient in ASTEPRO® ALLERGY

ANTIHITAMINE
NASAL SPRAY 

Azelastine Hydrochloride 
Nasal Spray
205.5 mcg per spray

             ANTIHISTAMINE NASAL SPRAY
Allergy 
            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)




                            

INGREDIENTS AND APPEARANCE

AZELASTINE HYDROCHLORIDE 
azelastine hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-020
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)	AZELASTINE HYDROCHLORIDE	205.5 ug

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
WATER (UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE (clear colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-020-51	1 in 1 CARTON	01/27/2025
1		60 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 58602-020-52	1 in 1 CARTON	01/27/2025
2		120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 58602-020-07	1 in 1 CARTON	01/27/2025
3		200 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA216561	01/27/2025

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-020) , MANUFACTURE(58602-020)