AZELASTINE HYDROCHLORIDE- azelastine hydrochloride spray, metered 
Walgreens

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Drug Facts

Active ingredient (in each spray)

Azelastine hydrochloride 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 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 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.

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

Inactive ingredients

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

Questions or comments?

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

Principal Display Panel - Bottle

Bottle LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-01

Azelastine Hydrpchloride Nasal Spray (205.5 mcg per spray)

ANTIHISTAMINE NASAL SPRAY

60 Metered Sprays

60mdBTL.jpg

Principal Display Panel - Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-03

Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)

60 Metered Sprays

ANTIHISTAMINE NASAL SPRAY

24 Hour Relief of:

Principal Display Panel - Bottle

Bottle LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-02

Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)

ANTIHISTAMINE NASAL SPRAY

120 Metered Sprays

120mdBTL.jpg

Principal Display Panel - Carton

CARTON LABEL - PRINCIPAL DISPLAY PANEL

NDC 0363-0653-04

Azelastine Hydrochloride Nasal Spray (205.5 mcg per spray)

120 Metered Sprays

ANTIHISTAMINE NASAL SPRAY

24 Hour Relief of:

120mdCTN.jpg

AZELASTINE HYDROCHLORIDE 
azelastine hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0653
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0653-031 in 1 CARTON06/25/2024
1NDC:0363-0653-0160 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0363-0653-041 in 1 CARTON06/25/2024
2NDC:0363-0653-02120 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
ANDAANDA21642106/25/2024
Labeler - Walgreens (008965063)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.255092496analysis(0363-0653) , manufacture(0363-0653)

Revised: 5/2024
Document Id: 8d163e33-7566-2442-1c08-880897f69716
Set id: ec268981-433f-b26b-4ff0-3a121e0a0d08
Version: 1
Effective Time: 20240514
 
Walgreens