Amneal Pharmaceuticals NY LLC

Azelastine HCl Azelastine AZELASTINE HYDROCHLORIDE AZELASTINE BENZALKONIUM CHLORIDE EDETATE DISODIUM HYPROMELLOSES WATER SODIUM CITRATE SUCRALOSE SORBITOL HYDROCHLORIC ACID SODIUM HYDROXIDE

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

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

 if you have ever had an allergic reaction to this product or any of its ingredients

have had recent nose ulcers or nose surgery have had a nose injury that has not healed

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

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.

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

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

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

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

Call 1-877-835-5472 (Mon-Fri, 9AM-5PM EST) Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807 Rev. 12-2021-00

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: ■ 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). 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 pic 1 pic 2 IMAGE 3 IMAGE 4 IMAGE 5 IMAGE 6 IMAGE 7

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