Label: AZELASTINE HCL- azelastine spray, metered

  • NDC Code(s): 69238-2147-3
  • Packager: Amneal Pharmaceuticals NY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 5, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each spray)

    Azelastine HCl 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
    • sneezing
    • itchy nose
  • Warnings

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

    Do not use

    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

    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

    When using this product

    • drowsiness may occur
      • avoid alcoholic drinks
      • alcohol, sedatives, and tranquilizers may increase drowsiness
      • be careful when driving motor vehicle or operation 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

    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

    Pregnancy/Breastfeeding

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    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

    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 flaps is not intact
  • Inactive ingredients

    Inactive ingredients

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

  • Questions

    Questions or Comments?

    Call 1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

    Distributed by:

    Amneal Pharmaceuticals LLC

    Bridgewater, NJ 08807

    Rev. 09-2021-00

  • User Guide

    Azelastine HCl Nasal Spray (205.5 mcg per spray)

     

    HOW TO START GETTING STEROID-FREE ALLERGY RELIEF RIGHT NOW

    This User Guide will give you detailed directions on how to prime the bottle, use the spray, and how to clean a clogged nozzle.

    Keep this User Guide as it contains important information.

    GET THE BOTTLE READY



    Remove the dust cover over the tip of the bottle

    and the white safety clip just under

    the shoulders of the bottle before using.                    

    pic 1
     PRIME THE BOTTLE


    WHEN TO PRIME
     

    • Before you use Azelastine HCl Nasal Spray for the first time
    • If you have not used Azelastine HCl Nasal Spray for 3 or more days
    • After you clean a clogged nozzle

    HOW TO PRIME

    • Aim bottle away from face.
    • Hold bottle as shown and pump until a fine mist appears.
    • If a fine mist does not appear after 6 sprays, your nozzle may be clogged. Please see “How to Clean a Clogged Nozzle” section.

     

    pic 2

     

    HOW TO USE


     Important: For use in your nose only

    STEP 1

    Blow your nose to clear your nostrils.

    STEP 2

    Tilt your head downward toward your toes.

     IMAGE 3

    STEP 3

    Hold bottle with thumb under bottle and

    spray nozzle between fingers.

    IMAGE 4

    STEP 4

    Close one nostril.

     IMAGE 5

    STEP 5

    Put the spray tip about ¼ inch to ½ inch into the other nostril.

    Hold bottle upright and aim the spray tip toward the back of your nose.

    STEP 6

    While sniffing gently, press the pump once or twice

    (according to dosing directions found in Table 1).

    Repeat Steps 4, 5 and 6 in other nostril.

    STEP 7

    Do not tilt your head back immediately after using Azelastine HCl Nasal Spray.

    This will help to keep the medicine from going into your throat,

    which may cause a bitter taste.

    STEP 8

    When you finish using your Azelastine HCl Nasal Spray, wipe the spray tip

    with a clean tissue or cloth. Put the clip and cap back on the bottle.

    FOR USE IN CHILDREN

    An adult should supervise use.

    (See Steps 1 through 8).

    SELECT THE DOSE

    DIRECTIONS

    Do not use more than directed

    TABLE 1

    adults & 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

    IMPORTANT INFORMATION FOR USE

    Remember, 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.

      *In clinical trials, drowsiness was observed in less than 4% of patients taking Azelastine HCl Nasal Spray.

    HOW TO CLEAN A CLOGGED NOZZLE
    • If you cannot get your Azelastine HCl Nasal Sprayto spray a fine mist,

      the nozzle may be clogged. Don’t try to unclog the nozzle

      with a pin or sharp object—that can damage it.

    • Unscrew the spray pump unit from the bottle

      by turning it to the left (counter-clockwise).

    IMAGE 6
    • Keep open bottle out of reach of children.
    • Fill a bowl or container with warm water. Soak only the

      spray pump unit in the warm water. Pump the nozzle several

      times while holding it under the water to clear the clog.

    IMAGE 7
    • Let the spray pump unit air dry before putting it back on.
    • Tightly screw pump unit back on the open bottle

      by turning clockwise (to the right).

    • After cleaning, follow the instructions for priming.

    QUESTIONS OR COMMENTS?

    1-877-835-5472 (Mon to Fri, 9AM to 5PM EST)

    Distributed by:

    Amneal Pharmaceuticals LLC

    Bridgewater, NJ  08807

    Rev. 12-2021-00

  • Principal Display Panel

    label

    ifc
  • INGREDIENTS AND APPEARANCE
    AZELASTINE HCL 
    azelastine spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69238-2147
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69238-2147-3200 in 1 BOTTLE06/07/2024
    11 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
    ANDAANDA21657606/07/2024
    Labeler - Amneal Pharmaceuticals NY LLC (123797875)