Combivent Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

The dose of Combivent Inhalation Aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Safety and efficacy of additional doses of Combivent Inhalation Aerosol beyond 12 puffs/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of Combivent Inhalation Aerosol have not been studied. It is recommended to “test-spray” three times before using for the first time and in cases where the aerosol has not been used for more than 24 hours.

Combivent Inhalation Aerosol is supplied as a metered-dose inhaler with a white mouthpiece which has a clear, colorless sleeve and an orange protective dust cap. The Combivent Inhalation Aerosol canister should be used with the Combivent Inhalation Aerosol actuator only. The actuator should not be used with other aerosol medications. Each actuation meters 21 mcg of ipratropium bromide and 120 mcg of albuterol sulfate from the valve and delivers 18 mcg of ipratropium bromide and 103 mcg of albuterol sulfate (equivalent to 90 mcg albuterol base) from the mouthpiece. Each 14.7 gram canister provides sufficient medication for 200 inhalations (NDC 0597-0013-14).

The canister should be discarded after the labeled number of actuations have been used. The amount of medication in each actuation cannot be assured after this point.

Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. For best results, store the canister at room temperature before use. Avoid excessive humidity. Shake the canister vigorously for at least 10 seconds before use.

Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

Warning: Contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm public health and the environment by destroying ozone in the upper atmosphere.

A notice similar to the above Warning has been placed in the information for the patient of this product under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are any questions about alternatives.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Ipratropium bromide licensed from: Boehringer Ingelheim International GmbH. Revised: October 11, 2005. FDA Rev date: 6/1/2006

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