Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.

Recommended Doses: Adults and children 12 years of age and older: The recommended starting and maximum dose is 220 mcg per day as two sprays in each nostril once daily.

Children 6 to 12 years of age: The recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. The maximum recommended dose is 220 mcg per day as two sprays per nostril once daily.

Nasacort AQ Nasal Spray is not recommended for children under 6 years of age since adequate numbers of patients have not been studied in this age group.

Individualization of Dosage: It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. In adults, when the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 mcg per day (one spray in each nostril once a day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled at 220 mcg/day.

In children six to twelve years of age, the recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. The maximum recommended daily dose in children 6 to 12 years of age is 220 mcg per day (two sprays in each nostril once daily). Some patients who do not achieve maximum symptom control at a dose of 110 mcg per day may benefit from a dose of 220 mcg given as two sprays in each nostril once daily. The minimum effective dose should be used to ensure continued control of symptoms. Once symptoms are controlled, pediatric patients may be able to be maintained on 110 mcg per day (1 spray in each nostril once daily).

An improvement in some patient symptoms may be seen within the first day of treatment, and generally, it takes one week of treatment to reach maximum benefit. Initial assessment for response should be made during this time frame and periodically until the patient's symptoms are stabilized. If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Nasacort AQ Nasal Spray should be discontinued. (See WARNINGS, PRECAUTIONS, Information for Patients, and ADVERSE REACTIONS.)

Directions For Use: Illustrated Patient's Instructions for use accompany each package of Nasacort AQ Nasal Spray.

Nasacort AQ Nasal Spray is a nonchlorofluorocarbon (non-CFC) containing metered-dose pump spray. The contents of one 6.5 gram sample bottle provide 30 actuations, and the contents of one 16.5 gram bottle provide 120 actuations. The bottle should be discarded when the labeled number of actuations have been reached even though the bottle is not completely empty.

It is supplied in a white high-density polyethylene container with a metered-dose pump unit, white nasal adapter, and patient instructions.

NDC 0075-1506-16

Keep out of reach of children.

Store at Controlled Room Temperature, 20 to 25°C (68 to 77°F) [see USP].

Sanofi-Aventis U.S. LLC Bridgewater, NJ 08807. Rev. September 2006. FDA rev date: 3/8/2004

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