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IMPORTANT SAFETY INFORMATION AND INDICATION

Do not use NICOTROL Inhaler if you are hypersensitive or allergic to nicotine, menthol, or to any ingredient in the product.

If you have cardiovascular, peripheral vascular, or bronchospastic diseases including asthma or chronic pulmonary disease, talk to your doctor about using the NICOTROL Inhaler. If you are under a doctor’s care for any condition, you should first discuss with your doctor the potential risks of using this product.

You should stop smoking completely before using NICOTROL Inhaler. You should not smoke or use other nicotine-containing products while under treatment with NICOTROL Inhaler.

Because nicotine is addictive, it is possible to become dependent on NICOTROL Inhaler. It is important to use it only for as long as needed to overcome your smoking habit. The safety of treatment with NICOTROL Inhaler for periods longer than 6 months has not been established, and such use is not recommended.

A special note about children and pets: The NICOTROL Inhaler can cause serious illness or be fatal in children and pets—even in very small amounts. If a child chews on or swallows new or used NICOTROL Inhaler cartridges, immediately call a doctor or call your regional poison center.

The specific effects of the NICOTROL Inhaler treatment on fetal development and nursing infants are unknown. Therefore, pregnant and nursing smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

You are likely to experience mild irritation of the mouth or throat, or cough when you first use the NICOTROL Inhaler. In clinical trials, the frequency of mouth or throat irritation, or coughing declined with continued use. The most common nicotine-related side effect was upset stomach. Other nicotine-related side effects were nausea, diarrhea, and hiccup. Smoking-related side effects included chest discomfort, bronchitis, and high blood pressure.

It is important to tell your doctor about any other medications you may be taking because they may need dosage adjustment.

INDICATION

NICOTROL Inhaler is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. It is available only by prescription and is recommended for use as part of a comprehensive behavioral smoking cessation program.

Please see Full Prescribing Information and Patient Information.

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