Label: CHILDREN ASTEPRO ALLERGY- azelastine hcl spray, metered

  • NDC Code(s): 0280-0066-01, 0280-0066-02, 0280-0066-03
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

    Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • nasal congestion
    • runny nose
    • sneezing
    • itchy nose
  • WARNINGS

    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 a 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
    • prime bottle again if not used for 3 or more days
    • use the spray
    • 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 yearsdo not use

  • Other information

    Other information

    • store between 20° to 25° C (68° to 77° F). Protect from freezing.
    • keep this carton and the enclosed User Guide for important information
    • do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • Questions or comments

    Questions or comments?

    1-800-317-2165 (Mon-Fri, 9AM-5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Childrens Astepro 120Azelastine HCl 205.5 mcg per spray

    ANTIHISTAMINE NASAL SPRAY

    FULL PRESCRIPTION STRENGTH

    STEROID FREE

    UP TO 24 HOUR RELIEF OF

    Nasal congestion
    Runny nose
    Sneezing
    Itchy nose

  • INGREDIENTS AND APPEARANCE
    CHILDREN ASTEPRO ALLERGY 
    azelastine hcl spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0066
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0066-0322 in 1 BOTTLE06/30/2022
    11 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0280-0066-0160 in 1 BOTTLE06/30/2022
    21 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0280-0066-02120 in 1 BOTTLE06/30/2022
    31 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21387206/27/2022
    Labeler - Bayer HealthCare LLC. (112117283)
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