When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to nicotine.

How to Use This Medicine:
Gum, Lozenge

• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Begin using this medicine on your quit day, even if you are not able to stop smoking immediately.
• Use at least the minimum number of suggested pieces of gum or lozenges per day for the first 6 weeks. Do not use more than 1 piece at the same time.
• Keep using this medicine for the full treatment time. If you feel you need to use this medicine for a longer period of time, talk to your doctor.
• Read the package label to find your correct dose. The dose is based on how soon you would normally smoke after you wake up in the morning.
• Do not eat or drink for 15 minutes before you use this medicine or while you have it in your mouth.
• You may feel tingling or a warm feeling in your mouth. This means the nicotine is being released.
• Gum:
  
  • Do not chew this medicine like regular gum. Chew it slowly until you feel tingling or taste a peppery flavor. Move it to the inside of your cheek until the tingling goes away. Chew it a few more times until the tingling returns, then move it to your other cheek or a different place in your mouth. Repeat this until the tingling stops, usually after about 30 minutes. Throw the gum away.
  • You may use a second piece of gum if you still feel strong cravings to smoke within the same hour. After that, you must wait until your next scheduled dose.
• Lozenge:
  
  • Minimize swallowing when the lozenge is in your mouth. This helps the medicine be absorbed through the tissue in your mouth. Occasionally move the lozenge from side to side in your mouth. Let it melt slowly. It should melt within 30 minutes. Do not bite, chew, or swallow the lozenge.
• Store this medicine at room temperature, away from heat and direct light. Wrap any used gum or leftover lozenge in a paper towel and throw it away so children or pets cannot get to it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Pregnant or breastfeeding women should only use this medicine as directed by a doctor. Smoking can seriously harm your unborn child. Try to stop smoking without using medicine. Although this medicine is believed to be safer than smoking, the risks of its use during pregnancy are not fully known.
• Tell your doctor if you have diabetes, heart problems, high blood pressure, a stomach ulcer, or phenylketonuria (PKU).
• This medicine may cause the following problems:
  
  • High blood pressure
  • Increase in heart rate
• If you are on a low-salt diet, talk to your doctor before you use this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, headache, upset stomach, drooling, vomiting, diarrhea, cold sweats, blurred vision, trouble hearing, confusion, fainting, or weakness
• Fast, slow, pounding, or uneven heartbeat
• Severe sore throat, open mouth sores or blisters

If you notice these less serious side effects, talk with your doctor:

• Mild nausea, constipation, heartburn
• Mouth, tooth, or jaw pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088