FOR INTRANASAL USE ONLY

IMPORTANT: FOLLOW INSTRUCTIONS CAREFULLY TO ENSURE PROPER DOSING.

DOSING: The dosage of azelastine hydrochloride nasal solution is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. For patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily. For patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily. Keep your head tilted downward when spraying. Alternate sprays between nostrils. Breathe gently to avoid drawing any medication into the throat. Follow the instructions below to use your Azelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray) pump.

TO PRIME:

1\. Remove and retain the white spray tip dust cover and white spray clip.

2\. Prime for initial use by putting two fingers on the shoulders of the spray pump unit and place your thumb on the bottom of the bottle. Press upward with thumb, release, and repeat until a fine mist appears (4 sprays or less). Now your pump is primed and ready to use.

3\. If the solution is delivered in a stream of liquid, it may fail to provide maximum benefit and cause some discomfort. A fine mist can be produced only by a rapid and firm pumping action.

4\. When 3 or more days have elapsed since the last use, the pump should be reprimed with 2 sprays or until a fine mist appears.

TO USE:

1\. Gently blow nose to clear nostrils.

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

3\. Place the spray tip ¼ to ½ inch into one nostril. Hold bottle vertically upright (as shown), allowing spray tip to aim toward the back of the nose. Close other nostril with finger, rapidly press once with thumb and sniff gently at the same time. You may feel a brief burning or stinging sensation after using the unit.

4\. Repeat in other nostril.

5\. For patients aged 12 and over who were instructed by their doctor to administer 2 sprays in each nostril, repeat Steps 2 and 3 for second spray, again alternating sprays between nostrils.

6\. Breathe in gently, and do not tilt head back after dosing to avoid drawing medication into the throat (where it will be tasted).

CAUTION: Keep bottle tightly closed and away from children. In case of accidental ingestion by a young child, seek professional assistance or contact a poison control center immediately. Do not spray in eyes.

NOTE: Keep the dust cover and safety clip on the spray pump unit when not in use. After each use and before replacing the dust cover, wipe the spray tip with a clean tissue or cloth.

TO CLEAN:

1\. If spray nozzle becomes clogged, DO NOT ATTEMPT TO CLEAR IT USING A POINTED OBJECT.Remove the spray pump unit from the bottle.

2\. Soak only the spray pump unit in warm water.Squirt several times while holding under water.

3\. Make sure the spray pump unit is dry.

4\. Reinsert the pump into the open bottle and tighten by turning clockwise.

5\. To avoid leakage, firm pressure is required to ensure that the pump is fully threaded onto the bottle.

6\. Follow instructions for priming.

Store upright at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle tightly closed and away from children.

241533

January 2009