Label: AZELASTINE HYDROCHLORIDE spray, metered

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

Drug Label Information

Updated May 14, 2024

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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
    • runny nose
    • 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 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 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:

    • Nasal congestion
    • Runny nose
    • Sneezing
    • Itchy nose
      60mdCTN.jpg
  • 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:

    • Nasal congestion
    • Runny nose
    • Sneezing
    • Itchy nose

    120mdCTN.jpg

  • 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 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)
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