PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


---

INDICATIONS & USAGE SECTION

Highlight: Azelastine HCl nasal spray, 0.1% is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)

1 INDICATIONS AND USAGE

Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Azelastine HCl nasal spray, 0.1%: 137 mcg of azelastine HCl, USP in each 0.137 mL spray. (3)

3 DOSAGE FORMS AND STRENGTHS

Azelastine HCl nasal spray, 0.1% is a nasal spray solution. Each spray of azelastine HCl nasal spray, 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine HCl, USP.

---

CONTRAINDICATIONS SECTION

Highlight: None. (4)

4 CONTRAINDICATIONS

None.

---

DRUG INTERACTIONS SECTION

7 DRUG INTERACTIONS

7.1 Central Nervous System Depressants

Concurrent use of azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see Warnings and Precautions (5.1)].

---

OVERDOSAGE SECTION

10 OVERDOSAGE

There have been no reported overdosages with azelastine HCl nasal spray, 0.1%. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of azelastine HCl nasal spray, 0.1% contains 30 mg of azelastine(HCl). Clinical trials in adults with single doses of the oral formulation of azelastine (HCl) (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to azelastine HCl nasal spray, 0.1%. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, azelastine HCl nasal spray, 0.1% should be kept out of the reach of children.

---

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION

Azelastine Hydrochloride (ay” ze las’ teen hye” droe klor’ ide) Nasal Spray, 0.1%

What is azelastine HCl nasal spray, 0.1%?

• Azelastine HCl nasal spray, 0.1% is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people age 5 and older and vasomotor rhinitis in people age 12 and older.
• Azelastine HCl nasal spray, 0.1% may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if azelastine HCl nasal spray, 0.1% is safe and effective in children with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 years of age.

What should I tell my healthcare provider before using azelastine HCl nasal spray, 0.1%?

Before using azelastine HCl nasal spray, 0.1%, tell your healthcare provider if you are:

• allergic to any of the ingredients in azelastine HCl nasal spray, 0.1%. See the end of this leaflet for a complete list of ingredients in azelastine HCl nasal spray, 0.1%.
• pregnant, or plan to become pregnant.
• breastfeeding, or plan to breastfeed. It is not known if azelastine HCl passes into your breast milk. You and your healthcare provider should decide if you will use azelastine HCl nasal spray, 0.1% if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine HCl nasal spray, 0.1% and other medicines may affect each other, causing side effects.

How should I use azelastine HCl nasal spray, 0.1%?

• Read theInstructions for Use at the end of this leaflet for information about the right way to use azelastine HCl nasal spray, 0.1%.
• Spray azelastine HCl nasal spray, 0.1% inyour nose only. Do not spray it into your eyes or mouth.
• Use azelastine HCl nasal spray, 0.1% exactly as your healthcare provider tells you to use it. *Do not use more than your healthcare provider tells you.
• Throw away your azelastine HCl nasal spray, 0.1% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
• If you use too much or a child accidentally swallows azelastine HCl nasal spray, 0.1%, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using azelastine HCl nasal spray, 0.1%?

Azelastine HCl nasal spray, 0.1% can cause sleepiness:

*Do not drive, operate machinery, or do other dangerous activities until you know how azelastine HCl nasal spray, 0.1% affects you. *Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine HCl nasal spray, 0.1%. It may make your sleepiness worse.

What are the possible side effects of azelastine HCl nasal spray, 0.1%?

The most common side effects of azelastine HCl nasal spray, 0.1% include:

• unusual bitter taste
• headache
• sleepiness
• nose burning, pain or discomfort
• runny nose
• scratchy or sore throat
• nosebleeds
• inflammation or swelling of the sinuses
• sneezing
• nausea
• dry mouth
• fatigue
• dizziness
• weight increase

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of azelastine HCl nasal spray, 0.1%. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store azelastine HCl nasal spray, 0.1%?

• Keep azelastine HCl nasal spray, 0.1% upright at 68° to 77°F (20° to 25°C).
• Do not freeze azelastine HCl nasal spray, 0.1%.
• Do not use azelastine HCl nasal spray, 0.1% after the expiration date “EXP” on the medicine label and box.

Keep azelastine HCl nasal spray, 0.1% and all medicines out of reach of children.

General information about the safe and effective use of azelastine HCl nasal spray, 0.1%.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use azelastine HCl nasal spray, 0.1% for a condition for which it was not prescribed. Do not give azelastine HCl nasal spray, 0.1% to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about azelastine HCl nasal spray, 0.1%. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azelastine HCl nasal spray, 0.1% that is written for health professionals.

For more information call 1-877-835-5472.

What are the ingredients in azelastine HCl nasal spray, 0.1%?

Active ingredient: Azelastine HCl, USP

Inactive ingredients: Benzalkonium chloride, citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride.

• Trademarks are the property of their respective owners.

Distributed by:
Amneal Pharmaceuticals LLC
****Bridgewater, NJ 08807

Rev. 10-2018-02

---

INSTRUCTIONS FOR USE SECTION

Instructions for Use

Azelastine Hydrochloride (ay” ze las’ teen hye” droe klor’ ide) Nasal Spray, 0.1%

For the correct dose of medicine:

• Keep your head tilted downward when spraying into your nostril.
• Change nostrils each time you use the spray. *Breathe gently and do not tip your head back after using the spray. This will keep the medicine from running down into your throat. You may get a bitter taste in your mouth.

Figure A identifies the parts of your azelastine HCl nasal spray, 0.1% pump

Before you use azelastine HCl nasal spray, 0.1% for the first time, you will need to prime the bottle.

Priming your azelastine HCl nasal spray, 0.1%

Remove the dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump**(See Figure B)**.


Hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and

• put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action. Repeat this until you see a fine mist**(See Figure C)**.
• To get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort.
• This should happen in 4 sprays or less.

Now your pump is primed and ready to use.


Do not use azelastine HCl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the*“Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%”** section below.

• If you do not use azelastine HCl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist.

Using your azelastine HCl nasal spray, 0.1%

Step 1. Blow your nose to clear your nostrils.

Step 2. Keep your head tilted downward toward your toes.

Step 3. Place the spray tip about ¼ inch to ½ inch into 1 nostril. Hold bottle upright and aim the

spray tip toward the back of your nose**(See Figure D)**.


Step 4. Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E).


Step 5. RepeatStep 3 andStep 4 in your other nostril.

Step 6. If your healthcare provider tells you to use 2 sprays in each nostril, repeatSteps 2 through 4 above for the second spray in each nostril.

Step 7. Breathe in gently, anddo not tilt your head back after using azelastine HCl nasal spray, 0.1%. This will help to keep the medicine from going into your throat.

Step 8. When you finish using your azelastine HCl nasal spray, 0.1%, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle.

Cleaning the Spray Tip of your azelastine HCl nasal spray, 0.1%

• The spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. Unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise)(See Figure F).
• Soak only the spray pump unit in warm water. Squirt the spray unit several times while holding it under water. Use the pumping action to clear the opening in the tip**(See Figure G)**.


• Let the spray pump unit air dry. Make sure it is dry before you put it back onto the bottle.
• Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right).
• To keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle.
• After cleaning, follow the instructions for priming.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:
Amneal Pharmaceuticals LLC
****Bridgewater, NJ 08807

Rev. 10-2018-02

---