Drug Information for ALVESCO (ciclesonide) Inhalation Aerosol 80 mcg, 160 mcgFor Oral Inhalation Only (Sepracor Inc.): 16 HOW SUPPLIED/STORAGE AND HANDLING

ALVESCO is available in the following strengths and canister presentations.

ALVESCO 80 mcg Inhalation Aerosol is supplied with a brown plastic actuator with a red dust cap. Each actuation of the inhaler delivers 80 mcg of ciclesonide from the actuator.

ALVESCO 160 mcg Inhalation Aerosol is supplied with a red plastic actuator with a red dust cap. Each actuation of the inhaler delivers 160 mcg of ciclesonide from the actuator.

ALVESCO canisters are for use with ALVESCO Inhalation Aerosol actuators only. The actuators are fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero.

Store at 25°C (77°F).

Excursions between 15° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. Keep out of reach of children.

CONTENTS UNDER PRESSURE

Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.