Patient's Instructions for Use
SHAKE WELL BEFORE EACH USE

NASONEX®
(mometasone furoate monohydrate)
Nasal Spray, 50 mcg*
*calculated on the anhydrous basis

Shake the bottle well before each use. Read complete instructions carefully and use only as directed.

1. Remove the plastic cap (Figure 1).
2. The very first time the spray is used, prime the pump by pressing downward on the shoulders of the white applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb (Figure 2). Press down and release the pump ten times or until a fine spray appears. DO NOT spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying two times or until a fine spray appears.
3. Gently blow your nose to clear the nostrils. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3). DO NOT spray directly onto nasal septum, the wall between the two nostrils.
4. For each spray, press firmly downward once on the shoulders of the white applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Breathe gently inward through the nostril (Figure 4).
5. Then breathe out through the mouth.
6. Repeat in the other nostril.
7. Wipe the nasal applicator with a clean tissue and replace the plastic cap.

Pediatric Use: Administration to young children should be aided by an adult. The Patient's Instructions for Use, Steps 1 to 7 should be followed.

The correct amount of medication in each spray can only be assured up to 120 sprays from the bottle even though the bottle is not completely empty. You should keep track of the number of sprays used from each bottle of NASONEX Nasal Spray, 50 mcg and discard the bottle after using 120 sprays.

Cleaning: Please see Applicator Cleaning Instructions on reverse.

Caution: NASONEX Nasal Spray, 50 mcg is formulated for once- or twice-daily dosing depending on your condition. You should use NASONEX Nasal Spray, 50 mcg, once or twice daily as directed. Since NASONEX Nasal Spray, 50 mcg is not intended to give rapid relief of your nasal symptoms, the prescribed dosage should not be increased by using more often than your physician prescribed in an attempt to increase its effectiveness. NASONEX Nasal Spray, 50 mcg, helps to control the your condition so it is important that you use it regularly as directed by your physician.

NASONEX NASAL Spray treats seasonal and year-round nasal allergy symptoms in adults and children 2 years and older. Based on single-day studies, done in a park, during pollen season or in a controlled pollen exposure room, improvement in nasal allergy symptoms has been shown to occur within 11 hours after the first dose. In other studies that lasted up to 2 weeks, improvement in nasal symptoms of seasonal allergic rhinitis was shown to occur within 2 days after the first dose. The full benefit of NASONEX Nasal Spray, 50 mcg, in allergic rhinitis is usually achieved within 1 to 2 weeks. NASONEX Nasal Spray can also be used to help prevent seasonal nasal allergy symptoms in adults and children 12 years and older, when treatment starts 2 to 4 weeks before the allergy season.

In patients aged 18 years and older, NASONEX Nasal Spray is also used to treat nasal polyps.

Side effects were generally mild and included headache, viral infection, sore throat, nosebleeds and coughing.

NASONEX Nasal Spray, 50 mcg should not be sprayed into the eyes.

Spraying NASONEX Nasal Spray, 50 mcg directly onto the nasal septum should be avoided.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light.

When NASONEX Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.

APPLICATOR CLEANING INSTRUCTIONS

1. To clean the nasal applicator, remove the plastic cap (Figure 1).
2. Pull gently upward on the white nasal applicator so that it comes free (Figure 2).
3. Soak the nasal applicator in cold tap water and/or rinse both ends of the nasal applicator under cold tap water and dry. (Figure 3).
4. Rinse the plastic cap under cold water and dry (Figure 4).
5. Reassemble the nasal applicator being certain the pump stem is reinserted into the applicator's center hole (Figure 5).
6. Reprime the pump by pressing downward on the shoulders of the white applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Press down and release the pump two times or until a fine spray appears. DO NOT spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying two times or until a fine spray appears (Figure 6).
7. Replace the plastic cap (Figure 7).

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