Nicorette gum and lozenges contain nicotine, the primary ingredient found in tobacco products.

Nicorette gum and lozenges are medical products used to aid in smoking cessation in adults. Using a controlled amount of nicotine helps reduce nicotine withdrawal symptoms when you quit smoking.

Nicorette may also be used for purposes not listed in this medication guide.

Do not use Nicorette if you are pregnant or breast-feeding unless your doctor has told you to.

Do not smoke or use other nicotine products (including snuff, chewing tobacco, nicotine patches, inhaler, or nasal spray) while you are using Nicorette gum or lozenges.

Ask a doctor or pharmacist before using Nicorette if you have heart disease, a heart rhythm disorder, circulation problems, high blood pressure, history of stroke or heart attack, mouth or dental problems, jaw problems that make chewing difficult, liver or kidney disease, diabetes, thyroid disorder, stomach ulcer, asthma or other breathing disorder, an adrenal gland tumor, or if you are on a low-salt diet.

Keep both used and unused Nicorette gum and lozenges out of the reach of children or pets. The amount of nicotine in a used or unused lozenge or piece of gum can be fatal to a child who accidentally sucks or chews on it.

Before taking this medicine

Ask a doctor or pharmacist if it is safe for you to use Nicorette if you have:

• heart disease, heart rhythm disorder;

• untreated or uncontrolled high blood pressure;

• diabetes;

• stomach ulcer;

• a history of seizures;

• a food allergy;

• if you have recently had a heart attack;

• if you are on a low salt diet; or

• if you are using any other smoking cessation medicine (bupropion, Zyban, or others).

Do not use Nicorette if you are pregnant unless your doctor has told you to. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Nicotine can pass into breast milk and may harm a nursing baby. Do not use Nicorette if you are breast-feeding unless your doctor has told you to.

Smoking cigarettes during pregnancy can cause low birth weight, miscarriage, or stillbirth. Using a nicotine replacement product during pregnancy or while breast-feeding may be safer than smoking. However, you should try to stop smoking without using a nicotine replacement product if you are pregnant or breast-feeding. Talk with your doctor about the best way for you to stop smoking.

Nicorette lozenges may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Do not give Nicorette to anyone under 18 years old without medical advice.

Nicorette is only part of a complete program of treatment that may also include counseling, group support, and behavior changes. Your success will depend on your participation in all aspects of your smoking cessation program.

Use Nicorette exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Nicorette comes with patient instructions for safe and effective use. Your dose will depend on how many cigarettes you smoked daily before quitting. Follow the guide in the patient instructions. Ask your doctor or pharmacist if you have any questions.

Do not smoke or use other nicotine products (including snuff, chewing tobacco, nicotine patches, inhaler, or nasal spray). Using many forms of nicotine together can be dangerous.

To use Nicorette gum:

• Chew the Nicorette gum slowly and stop chewing when your mouth starts to tingle. "Park" the gum between your cheek and gum and leave it there until the tingly feeling is gone. Then slowly chew a few more times until the tingling returns. Park the gum again in a different place in your mouth.

• Remove a piece of gum after 30 minutes, or when chewing no longer causes the tingly feeling.

• If you have very strong or frequent cravings, you may chew a new piece of gum within 60 minutes.

• Avoid chewing one piece of gum right after the other, or you may have side effects such as hiccups, heartburn, or nausea.

• For best results, use at least 9 pieces of gum per day for the first 6 weeks of treatment. Do not use more than 24 pieces of gum per day.

To use Nicorette lozenges:

• Place the Nicorette lozenge in your mouth and allow it to dissolve slowly over 20 to 30 minutes, without chewing or swallowing.

• Move the lozenge from one side of your mouth to the other until it has completely dissolved.

• You may notice a warm or tingly feeling in your mouth.

• For best results, use at least 9 lozenges per day for the first 6 weeks of treatment. Do not use more than 5 Nicorette lozenges in 6 hours (20 lozenges per day).

After removing the gum or lozenge, wrap it in paper and throw it away in a place where children and pets cannot reach it.

Do not use Nicorette for longer than 12 weeks without the advice of your doctor.

Do not use more than one lozenge or piece of gum at a time. Do not use the gum and lozenges together at the same time.

Store at room temperature away from moisture, heat, and light.

Keep both used and unused gum and lozenges out of the reach of children or pets.

Ask a doctor or pharmacist if it is safe for you to use Nicorette if you have:

• heart disease, heart rhythm disorder;

• untreated or uncontrolled high blood pressure;

• diabetes;

• stomach ulcer;

• a history of seizures;

• a food allergy;

• if you have recently had a heart attack;

• if you are on a low salt diet; or

• if you are using any other smoking cessation medicine (bupropion, Zyban, or others).

Do not use Nicorette if you are pregnant unless your doctor has told you to. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Nicotine can pass into breast milk and may harm a nursing baby. Do not use Nicorette if you are breast-feeding unless your doctor has told you to.

Smoking cigarettes during pregnancy can cause low birth weight, miscarriage, or stillbirth. Using a nicotine replacement product during pregnancy or while breast-feeding may be safer than smoking. However, you should try to stop smoking without using a nicotine replacement product if you are pregnant or breast-feeding. Talk with your doctor about the best way for you to stop smoking.

Nicorette lozenges may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Do not give Nicorette to anyone under 18 years old without medical advice.

Since Nicorette is used as needed, you are not likely to miss a dose. Do not use more than 20 lozenges or 24 pieces of gum per day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of nicotine in a used or unused lozenge or piece of gum can be fatal to a child who accidentally sucks or chews on it. Seek emergency medical attention if this happens.

Overdose symptoms may include severe dizziness, nausea, vomiting, diarrhea, weakness, and fast heart rate.

Do not eat or drink anything within 15 minutes before using the gum or lozenge or while the medicine is in your mouth.

Get emergency medical help if you have any of these signs of an allergic reaction to Nicorette: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Nicorette and call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;

• blisters inside your mouth;

• problems with your teeth or jaw; or

• wheezing, tightness in your chest, trouble breathing.

Common Nicorette side effects may include:

• mild dizziness;

• dry mouth, upset stomach, burping, or hiccups;

• mouth or throat soreness;

• changes in taste; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with nicotine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.