Drug Information for Intal Inhaler (cromolyn sodium inhalation aerosol) (King Pharmaceuticals, Inc.): How Supplied

  • Intal Inhaler is supplied as an aerosol canister which provides 112 metered dose actuations from the 8.1 gram inhaler and 200 metered dose actuations from the 14.2 gram inhaler. The correct amount of medication in each inhalation cannot be assured after 112 actuations from the 8.1 gram canister or 200 actuations from the 14.2 gram canister even though the canister may not feel completely empty. The canister should be discarded when the labeled number of actuations have been used.

    Each actuation delivers 1 mg cromolyn sodium through the valve and 800 mcg through the mouthpiece to the patient. The Intal Inhaler canister and accompanying mouthpiece are designed to be used together. The Intal Inhaler canister should not be used with other mouthpieces and the supplied mouthpiece should not be used with other products’ canisters. Intal Inhaler is supplied with a white plastic mouthpiece with blue dust cap and patient instructions.

    NDC 60793-011-14 ......................... 14.2 g canister

    NDC 60793-011-08 .......................... 8.1 g canister

    Store between 15° to 30°C (59° to 86°F). Contents under pressure. Do not puncture, incinerate, or place near sources of heat. Exposure to temperatures above 120°F may cause bursting. Avoid spraying in eyes. Keep out of the reach of children.

    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 CFC-12 (dichlorodifluoromethane) and CFC-114 (dichlorotetrafluoroethane), 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” portion of this package insert 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 questions about alternatives.

    Rx only

    Intal® is a registered trademark of King Pharmaceuticals, Inc.

    Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

    Manufactured by: Health Care Specialties Division, 3M Health Care Limited, Loughborough, England LE11 1EP

    Made in United Kingdom.

    Prescribing Information as of September 2005.

  • Drug Information Provided by National Library of Medicine (NLM).