AZELASTINE HYDROCHLORIDE- azelastine hydrochloride spray, metered 
Allegiant Health

----------

479 - Azelastine hydrochloride

Active ingredient(s)

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

Antihistamine

Use(s)

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 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 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 breastfeeding,

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.

Directions

adults and children 12 years and older: 

This product may be used either once or twice a day:

children 6 years to 11 years:

children under 6 years: do not use

Other information

Inactive ingredients

benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose

Questions/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

Azelastine hydrochloride label

Azelastine hydrochloride label

Azelastine hydrochloride carton

Azelastine hydrochloride carton

Azelastine hydrochloride insert

Azelastine hydrochloride insert

Azelastine hydrochloride insert

Azelastine hydrochloride insert

AZELASTINE HYDROCHLORIDE 
azelastine hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-479
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-479-641 in 1 CARTON05/02/2025
160 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21642105/02/2025
Labeler - Allegiant Health (079501930)

Revised: 5/2025
Document Id: a38d6984-143a-4e7e-802a-269070c5e13e
Set id: cc7ddac6-95fa-4bc0-824d-f80e404e8d32
Version: 2
Effective Time: 20250502
 
Allegiant Health