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Azelastine HCl Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. Amneal Pharmaceuticals NY LLC

Generic: azelastine is used for the treatment of Conjunctivitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Vasomotor

Azelastine HCl spray, metered - image

  1. FDA Adverse Reactions

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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:

â– once daily: use 2 sprays in each nostril; OR

â– twice daily: use 1 or 2 sprays in each nostril every 12 hours

â– do not use more than 4 sprays in each nostril in a 24 hour period

children 6 years to 11 years
â– an adult should supervise use

â– 1 spray in each nostril every 12 hours

â– 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 20Ëš to 25ËšC (68Ëš to 77ËšF). 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.                    
 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.

 



 
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.

 

STEP 3

Hold bottle with thumb under bottle and

spray nozzle between fingers.

STEP 4

Close one nostril.

 

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:

â–  once daily : use 2 sprays in each nostril; OR

â–  twice daily : use 1 or 2 sprays in each nostril every 12 hours

â– do not use more than 4 sprays in each nostril in a 24 hour period

children 6 years to 11 years
â– an adult should supervise use

â– 1 spray in each nostril every 12 hours

â– 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).
  • 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.
  • 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

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DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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