AZELASTINE HCL- azelastine spray, metered 
Amneal Pharmaceuticals NY LLC

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Azelastine HCl Nasal Spray (205.5 mcg per spray)
Drug Facts

Active ingredient (in each spray)

Azelastine HCl 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:

Warnings

Only for use in the nose. Do not spray in eyes or mouth.

Do not use

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

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

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

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

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

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).

Directions

Directions

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

Other information

Inactive ingredients

Inactive ingredients

benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol and sucralose

Questions

Questions or Comments?

Call 1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 09-2021-00

User Guide

Azelastine HCl 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 dust cover over the tip of the bottle

and the white safety clip just under

the shoulders of the bottle before using.                    

pic 1
 PRIME THE BOTTLE


WHEN TO PRIME
 

HOW TO PRIME

 

pic 2

 

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.

 IMAGE 3

STEP 3

Hold bottle with thumb under bottle and

spray nozzle between fingers.

IMAGE 4

STEP 4

Close one nostril.

 IMAGE 5

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 HCl 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 HCl 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:

HOW TO CLEAN A CLOGGED NOZZLE
IMAGE 6
IMAGE 7

QUESTIONS OR COMMENTS?

1-877-835-5472 (Mon to Fri, 9AM to 5PM EST)

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ  08807

Rev. 12-2021-00

Principal Display Panel

label

ifc
AZELASTINE HCL 
azelastine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69238-2147
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X) AZELASTINE HYDROCHLORIDE205.5 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69238-2147-3200 in 1 BOTTLE06/07/2024
11 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21657606/07/2024
Labeler - Amneal Pharmaceuticals NY LLC (123797875)

Revised: 6/2024
Document Id: 3de9f1ce-b85d-41d9-a7be-c616715d6a23
Set id: 82610437-25f4-4ae0-9d6a-381e9932f87d
Version: 9
Effective Time: 20240605
 
Amneal Pharmaceuticals NY LLC