Important safety information and consumer warnings you should know about nicotine replacement.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Brand Names: US
GoodSense Nicotine [OTC] Nicoderm CQ [OTC] Nicorelief [OTC] Nicorette Mini [OTC] Nicorette Starter Kit [OTC] Nicorette [OTC] Nicotine Mini [OTC] Nicotine Step 1 [OTC] Nicotine Step 2 [OTC] Nicotine Step 3 [OTC] Nicotrol Nicotrol NS Thrive [OTC]
What is this drug used for?
- It is used to treat nicotine withdrawal.
- It is used to curb the craving to smoke.
What do I need to tell my doctor BEFORE I take this drug?
- If you have an allergy to nicotine or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Chest pain or pressure, a heartbeat that does not feel normal, or a recent heart attack.
- If you still smoke, chew tobacco, or use other products that have nicotine while using this drug.
- If you have temporomandibular joint (TMJ) disease.
- If you have asthma or nose problems like allergies, runny or stuffy nose, or nasal polyps.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
- Tell all of your healthcare providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Get counseling to help you quit smoking.
- Do not use more than told. Unsafe side effects may happen.
- Tell your doctor if you are taking another drug to help you stop smoking.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
- When you stop smoking, other drugs may be affected. Talk with your doctor.
- Tell your doctor if you have not been able to quit smoking after using this drug for as long as it says to use it.
- If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
- If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
- This drug may cause harm or be deadly if used or swallowed by children or pets. If a child uses this drug or if this drug is swallowed by a child or pet, call a doctor or poison control center right away.
- If you are 65 or older, use this drug with care. You could have more side effects.
- This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
- Gum chewing may cause problems with dental work.
- The patch may have metal. Take off the patch before an MRI.
- If you have strange dreams or other trouble sleeping, take off the patch at bedtime.
- This drug may cause harm if chewed or swallowed. If this drug has been put in the mouth, call a doctor or poison control center right away.
- If the bottle breaks, do not get this drug on your skin. If it does get on your skin wash off with water right away.
- During the first week, it is common to have a hot, peppery feeling in the back of the throat or nose, sneezing, coughing, watery eyes, or runny nose. Using this drug on a regular basis during the first week will help you adjust to the side effects. If these side effects do not get better after a week, call your doctor.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Mood changes.
- Feeling confused.
- Chest pain or pressure, a fast heartbeat, or an abnormal heartbeat.
- A burning, numbness, or tingling feeling that is not normal.
- Upset stomach or throwing up.
- Feeling tired or weak.
- Cold sweats.
- Blurred eyesight.
- Change in hearing.
- Nose sores.
- Mouth sores.
Gum and lozenges:
- Sore throat.
- Jaw pain.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Trouble sleeping.
- Bad dreams.
- Feeling nervous and excitable.
- Joint pain.
- Back pain.
- Irritation where this drug is used.
Gum and lozenges:
- Mouth tingling.
- Gum changes.
- Runny nose.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to your national health agency.
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- For breathing in only.
- Keep out of your eyes.
- Clean the mouthpiece often with soap and water.
- The gum comes in 2 doses. If you smoke your first cigarette of the day within 30 minutes of waking use the 4 mg dose. If you smoke your first cigarette of the day more than 30 minutes after waking use the 2 mg dose.
- Use right after opening.
- Do not swallow gum.
- Chew slowly until there is a tingling or peppery taste in the mouth.
- Then place between the cheek and gum.
- After the taste or tingle is gone, chew again slowly.
- Put between the cheek and gum at some other site once the taste or tingle comes back.
- Keep repeating this for about 30 minutes or until the taste or tingle is gone.
- Do not eat or drink within 15 minutes before using the gum or while you are using it.
- If needed, you may use a second piece within the hour. Do not use 1 piece right after the other.
- The patch comes in 3 doses. If you smoke 11 or more cigarettes a day start with the 21 mg patch (step 1). If you smoke 10 or less cigarettes a day start with the 14 mg patch (step 2).
- Put patch on clean, dry, healthy skin on the chest, back, belly, or upper arm. Move the site with each new patch.
- Put patch on a site without hair.
- Wash your hands after use.
- Each patch can stay on for 16 to 24 hours. If you crave cigarettes when you wake up, wear the patch for 24 hours.
- Do not leave on the skin for more than 24 hours.
- Do not put on more than 1 patch at a time.
- Do not use patches that are cut or do not look right.
- The lozenge comes in 2 doses. If you smoke your first cigarette of the day within 30 minutes of waking use the 4 mg dose. If you smoke your first cigarette of the day more than 30 minutes after waking use the 2 mg dose.
- Use right after opening.
- Suck oral lozenge. Do not chew, break, or crush it. Do not swallow it whole.
- Move this drug to the other side of the mouth every so often while it dissolves. This may take about 20 to 30 minutes.
- Try not to swallow very often while you are sucking on this drug.
- Do not eat or drink within 15 minutes before using the lozenge or while you are using it.
- Do not use more than 1 lozenge at a time. Do not use 1 lozenge right after another.
- For the nose only.
- Keep out of your eyes.
- You will need to prime the pump before first use. You may also need to prime the pump if it has not been used for some time. Be sure you know when you need to prime the pump and how to do it. Talk with the doctor or pharmacist if you have questions.
- Blow your nose before use.
- When using, tilt your head back.
- Spray up the nose only. Do not spray onto the wall joining the two nostrils.
- Do not sniff, swallow, or breathe in through your nose while you are using your dose of this drug.
- Breathe out from your mouth.
- Put the cap back on after you are done using your dose.
What do I do if I miss a dose?
- Use a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not use 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
- Store at room temperature.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Wrap the gum in paper before you throw it away.
- Wrap any part not used all the way in paper before you throw it away.
- After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
General drug facts
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.