Label: AZELASTINE HYDROCHLORIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 2, 2025

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  • 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:

    • nasal congestion
    • runny nose
    • sneezing
    • itchy nose
  • Warnings

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

    Do not use if you have

    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

    • 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 olderThis 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 spraysin 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 spraysin each nostril in a 24 hour period
    children under 6 yearsdo 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/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

  • INGREDIENTS AND APPEARANCE
    AZELASTINE HYDROCHLORIDE 
    azelastine hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-478
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-478-63120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)05/02/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21642105/02/2025
    Labeler - Allegiant Health (079501930)
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