Label: AZELASTINE HYDROCHLORIDE spray, metered

  • NDC Code(s): 0363-0653-01, 0363-0653-02, 0363-0653-03, 0363-0653-04, view more
    0363-0653-05
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 2, 2025

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  • 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:

    • nasal congestion
    • sneezing
    • runny nose
    • 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 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°C to 25°C (68°F to 77°F). Protect from freezing.
    • keep this carton and the enclosed User Guide for important information
    • do not use if sealed package is torn or opened
  • Inactive ingredients

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

  • Questions or comments?

    call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel - Bottle

  • Principal Display Panel - Carton

  • Principal Display Panel - Bottle only

    Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine

    WALGREENS Allergy Nasal Spray

  • Principal Display Panel

    Compare to the active ingredient in Astepro® Allergy Spray††

    24 HOUR RELIEF

    Allergy Nasal Spray

    AZELASTINE HYDROCHLORIDE 205.5 mcg per spray/

    ANTIHISTAMINE

    24 Hour

    • Up to 24-hour relief of nasal congestion, runny nose, sneezing & itchy nose
    • Steroid free
    • Alcohol free 
    • Fragrance free

    METERED SPRAYED

    FL OZ (mL)

    ††This product is not manufactured or distributed by Cooper Consumer Health SAS, owner of the registered trademark Astepro® 

    DISTRIBUTED BY: WALGREENS CO.

    DEERFIELD, IL 60015

  • Package label

    Azelastine Hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

    WALGREENS Allergy Nasal Spray

  • INGREDIENTS AND APPEARANCE
    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 CARTON07/01/2025
    1NDC:0363-0653-0160 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0363-0653-041 in 1 CARTON07/01/2025
    2NDC:0363-0653-02120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0363-0653-02120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/01/2025
    4NDC:0363-0653-052 in 1 CARTON07/01/2025
    4120 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
    ANDAANDA21642107/01/2025
    Labeler - Walgreens (008965063)
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