TOPCARE NICOTINE- nicotine polacrilex gum, chewing

topcare nicotine by

Drug Labeling and Warnings

topcare nicotine by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, L. Perrigo Company, Fertin Pharma A/S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 2 mg nicotine)

Purpose

Stop smoking aid

Use

• reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

• a sodium-restricted diet
• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
• high blood pressure not controlled with medication. Nicotine can increase blood pressure.
• stomach ulcer or diabetes
• history of seizures

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug
• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth, teeth or jaw problems occur
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
• you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• if you are under 18 years of age, ask a doctor before use
• before using this product, read the enclosed User’s Guide for complete directions and other important information
• begin using the gum on your quit day
• if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg
• if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 piece every 1 to 2 hours	1 piece every 2 to 4 hours	1 piece every 4 to 8 hours

• nicotine gum is a medicine and must be used a certain way to get the best results
• chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
• repeat this process until most of the tingle is gone (about 30 minutes)
• do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
• to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
• if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
• do not use more than 24 pieces a day
• it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information

• each piece contains: calcium 80 mg and sodium 11 mg
• store at 20-25oC (68-77oF)
• protect from light

Inactive ingredients

acesulfame potassium, calcium carbonate, carnauba wax, gelatin, gum base, mannitol, menthol, natural and artificial flavors, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sucralose, talc, titanium dioxide, xylitol

Questions or comments?

call 1-866-677-7858

Consumer Information

Nicotine Polacrilex Gum

2 mg and 4 mg User’s Guide

How To Use Nicotine Polacrilex Gum To Help You Quit Smoking.

• Not for sale to those under 18 years of age
• Proof of age required
• Not for sale in vending machines or from any source where proof of age cannot be verified

Keys To Success.

• 1. You must really want to quit smoking for Nicotine Polacrilex Gum to help you.
• 2. You can greatly increase your chances for success by using a least 9 to 12 pieces every day when you start using Nicotine Polacrilex Gum. See chart on back side of leaflet.
• 3. You should continue to use Nicotine Polacrilex Gum as explained in this User’s Guide for 12 full weeks. If you feel you need to use Nicotine Polacrilex Gum for a longer period to keep from smoking, talk to your health care provider.
• 4. Nicotine Polacrilex Gum works best when used together with a support program – See information for instructions on enrollment in the SmokeFreeHabits.com Free & Personalized Support Plan.
• 5. If you have trouble using Nicotine Polacrilex Gum, ask your doctor, pharmacist or health care professional.
• 6. To request a free audio CD containing tips to help make quitting easier, call 1-866-677-7858 (ONE CD PER CUSTOMER).

So You Decided To Quit.

Congratulations. Your decision to stop smoking is an important one. That’s why you’ve made the right choice choosing Nicotine Polacrilex Gum. Your own chances of quitting smoking depend on how much you want to quit, how strongly you are addicted to tobacco, and how closely you follow a quitting program like the one that comes with Nicotine Polacrilex Gum.

Quitting Smoking Is Hard!

If you’ve tried to quit before and haven’t succeeded, don’t be discouraged! Quitting isn’t easy. It takes time, and most people try a few times before they are successful. The important thing is to try again until you succeed. This User’s Guide will give you support as you become a nonsmoker. It will answer common questions about Nicotine Polacrilex Gum and give you tips to help you stop smoking, and should be referred to often.

Where To Get Help.

You are more likely to stop smoking by using Nicotine Polacrilex Gum with a support program that help break your smoking habit. There may be support groups in your area for people trying to quit. Call your local chapter of the American Lung Association, American Cancer Society or American Heart Association for further information. Toll free phone numbers are printed on the Wallet Card on the bottom of this User’s Guide.

If you find you cannot stop smoking or if you start smoking again after using Nicotine Polacrilex Gum, remember breaking this addiction doesn’t happen overnight. You may want to talk to a health care professional who can help you improve your chances of quitting the next time you try Nicotine Polacrilex Gum or another method.

Let’s Get Organized.

Your reason for quitting may be a combination of concerns about health, the effect of smoking on your appearance, and pressure from your family and friends to stop smoking. Or maybe you’re concerned about the dangerous effects of secondhand smoke on the people you care about. All of these are good reasons. You probably have others. Decide your most important reasons, and write them down on the wallet card on the back of the User’s Guide. Carry this card with you. In difficult moments, when you want to smoke, the card will remind you why you are quitting.

What You’re Up Against.

Smoking is addictive in two ways. Your need for the nicotine has become both physical and mental. You must overcome both addictions to stop smoking. So while Nicotine Polacrilex Gum will lessen your body’s physical addiction to nicotine, you’ve got to want to quit smoking to overcome the mental dependence on cigarettes. Once you’ve decided that you’re going to quit, it’s time to get started. But first, there are some other important warnings you should consider.

Some Important Warnings.

This product is only for those who want to stop smoking. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

• a sodium-restricted diet
• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
• stomach ulcer or diabetes
• history of seizures

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug
• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth, teeth or jaw problems occur
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
• oral blistering occurs (for cinnamon flavor)
• you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Let’s Get Started.

Becoming a nonsmoker starts today. First, check that you have bought the right starting dose. If you smoke you first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum 4 mg. If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg. Next read through the entire User’s Guide carefully. Then, set your personalized quitting schedule. Take out a calendar that you can use to track your progress, and identify four dates, using the reminders on the back side of this leaflet:

STEP 1. (Weeks 1-6). Your quit date (and the day you’ll start using Nicotine Polacrilex Gum).

Choose your quit date (it should be soon). This is the day you will begin using Nicotine Polacrilex Gum to satisfy your cravings for nicotine. For the first six weeks, you’ll use a piece of Nicotine Polacrilex Gum every hour or two. Be sure to read the How To Use Nicotine Polacrilex Gum section. Place the Step 1 reminder on this date.

STEP 2. (Weeks 7-9). The day you’ll start reducing your use of Nicotine Polacrilex Gum

After six weeks, you’ll begin gradually reducing your Nicotine Polacrilex Gum usage to one piece every two to four hours. Place the Step 2 reminder on this date (the first day of week seven).

STEP 3. (Weeks 10-12). The day you’ll further reduce you use of Nicotine Polacrilex Gum.

Nine weeks after you begin using Nicotine Polacrilex Gum, you will further reduce your nicotine intake by using one piece every four to eight hours. Place the step 3 reminder on this date (the first day of week ten). For the next three weeks, you’ll use a piece of Nicotine Polacrilex Gum every four to eight hours.

End of treatment: The day you’ll complete Nicotine Polacrilex Gum therapy.

Identify the date thirteen weeks after the date you choose in Step 1, and place the “EX-SMOKER” reminder on your calendar.

Plan Ahead.

Because smoking is an addiction, it is not easy to stop. After you’ve given up cigarettes, you will still have a strong urge to smoke. Plan ahead NOW for these times, so you’re not defeated in a moment of weakness. The following tips may help:

• Keep the phone numbers of supportive friends and family members handy.
• Keep a record of your quitting process. Track the number of Nicotine Polacrilex Gum pieces you use each day, and whether you feel a craving for cigarettes. In the event that you slip, immediately stop smoking and resume your quit attempt with the Nicotine Polacrilex Gum program.
• Put together an Emergency Kit that includes items that will help take your mind off occasional urges to smoke. Include cinnamon gum or lemon drops to suck on, a relaxing CD and something for your hands to play with, like a smooth rock, rubber band, or small metal balls.
• Set aside some small rewards, like a new magazine or a gift certificate from your favorite store, which you’ll “give” yourself after passing difficult hurdles.
• Think now about the times when you most often want a cigarette, and then plan what else you might do instead of smoking. For instance, you might plan to take your coffee break in a new location, or take a walk right after dinner, so you won’t be tempted to smoke.

How Nicotine Polacrilex Gum Works.

Nicotine Polacrilex Gum sugar-free chewing gum pieces provide nicotine to your system – they work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms. Nicotine Polacrilex Gum provides a lower level of nicotine to your blood than cigarettes, and allows you to gradually do away with your body’s need for nicotine. Because Nicotine Polacrilex Gum does not contain the tar or carbon monoxide of cigarette smoke, it does not have the same health dangers as tobacco. However, it still delivers nicotine, the addictive part of cigarette smoke. Nicotine can cause side effects such as a headache, nausea, upset stomach, and dizziness.

How To Use Nicotine Polacrilex Gum.

If you are under 18 years of age, ask a doctor before use. Before you can use Nicotine Polacrilex Gum correctly, you have to practice! That sounds silly, but isn’t. Nicotine Polacrilex Gum isn’t like ordinary chewing gum. It’s a medicine, and must be chewed a certain way to work right. Chewed like ordinary gum, Nicotine Polacrilex Gum won’t work well and can cause side effects. An overdose can occur if you chew more than one piece of Nicotine Polacrilex Gum at the same time, or if you chew many pieces one after another. Read all the following instructions before using Nicotine Polacrilex Gum. Refer to them often to make sure you’re using Nicotine Polacrilex Gum correctly. If you chew too fast, or do not chew correctly, you may get hiccups, heartburn, or other stomach problems. Don’t eat or drink for 15 minutes before using Nicotine Polacrilex Gum, or while chewing a piece. The effectiveness of Nicotine Polacrilex Gum may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks.

• 1. Begin using Nicotine Polacrilex Gum on your quit day.
• 2. To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum according to the dosage schedule on the back of this leaflet.
• 3. Chew each Nicotine Polacrilex Gum piece very slowly several times.
• 4. Stop chewing when you notice a peppery taste, or slight tingling in your mouth. (This usually happens after about 15 chews, but may vary from person to person.)
• 5. “PARK” the Nicotine Polacrilex Gum piece between your cheek and gum, and leave it there.
• 6. When peppery taste and tingle is almost gone (in about minute), start to chew a few times slowly again. When the taste or tingle returns, stop again.
• 7. Park the Nicotine Polacrilex Gum piece again (in a different place in your mouth).
• 8. Repeat steps 3 to 7 (chew, chew, park) until most of the nicotine is gone from the Nicotine Polacrilex Gum piece (usually happens in about half an hour; the peppery taste and tingle won’t return.)
• 9. Wrap the used Nicotine Polacrilex Gum piece in paper and throw away in the trash.

The following chart lists the recommended usage schedule for Nicotine Polacrilex Gum:
Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 piece every 1 to 2 hours	1 piece every 2 to 4 hours	1 piece every 4 to 8 hours
DO NOT USE MORE THAN 24 PIECES PER DAY.

To improve your chances of quitting, use at least 9 pieces of Nicotine Polacrilex Gum a day. If you experience strong or frequent cravings you may use a second piece within the hour. However, do not continuously use one piece after another, since this may cause you hiccups, heartburn, nausea or other side effects.

How To Reduce Your Nicotine Polacrilex Gum Usage.

The goal of using Nicotine Polacrilex Gum is to slowly reduce your dependence on nicotine. The schedule for using Nicotine Polacrilex Gum will help you reduce your craving gradually as you reduce and then stop your use of Nicotine Polacrilex Gum. Here are some tips to help you cut back during each step and then stop using Nicotine Polacrilex Gum:

• After a while, start chewing each Nicotine Polacrilex Gum piece for only 10 to 15 minutes, instead of half an hour. Then, gradually begin to reduce the number of pieces used.
• Or, try chewing each piece for longer than half an hour, but reduce the number of pieces you use each day.
• Substitute ordinary chewing gum for some of the Nicotine Polacrilex Gum pieces you would normally use. Increase the number of pieces of ordinary gum as you cut back on the Nicotine Polacrilex Gum pieces.
• Check how well you’ve reduced your daily usage of Nicotine Polacrilex Gum in Weeks 10 to 12. You should only be using about 3 to 5 pieces a day. Get ready to stop.

The following tips may help you try to stop Nicotine Polacrilex Gum when you have completed treatment.

• Set a stop date.
• Use the same number of pieces of confectionary gum or mints as you were using Nicotine Polacrilex Gum per day. At the times when you have an urge to use Nicotine Polacrilex Gum, use a strong flavored gum or mint such as cinnamon or peppermint.
• Reduce the number of pieces of gum or mints you use by one piece per day until you do not need to use any gum or mints.

Talk to your doctor or health care provider if you:

• still feel the need to use Nicotine Polacrilex Gum at the end of week 12 to keep from smoking
• start using Nicotine Polacrilex Gum again after stopping
• start smoking again

Tips To Make Quitting Easier.

Within the first few weeks of giving up smoking, you may be tempted to smoke for pleasure, particularly after completing a difficult task, or at a party or bar. Here are some tips to help get you through the important first stages of becoming a nonsmoker:

On your Quit Day:

• Ask your family, friends and coworkers to support you in your efforts to stop smoking.
• Throw away all your cigarettes, matches, lighters, ashtrays, etc.
• Keep busy on your quit day. Exercise. Go to a movie. Take a walk. Get together with friends.
• Figure out how much money you’ll save by not smoking. Most ex-smokers can save more than $1,000 a year.
• Write down what you will do with the money you save.
• Know your high risk situations and plan ahead how you will deal with them.
• Keep Nicotine Polacrilex Gum near your bed, so you’ll be prepared for any nicotine cravings when you wake up in the morning.
• Visit your dentist and have your teeth cleaned to get rid of the tobacco stains.

Right After Quitting:

• During the first few days after you’ve stopped smoking, spend as much time as possible at places where smoking is not allowed.
• Drink large quantities of water and fruit juices.
• Try to avoid alcohol, coffee and other beverages you associate with smoking.
• Remember that temporary urges to smoke will pass, even if you don’t smoke a cigarette.
• Keep your hands busy with something like a pencil or paper clip.
• Find other activities which help you relax without cigarettes.
• Swim, jog, take a walk, play basketball.
• Don’t worry too much about gaining weight, Watch what you eat, take time for daily exercise, and change your eating habits if you need to.
• Laughter helps. Watch or read something funny.

What to Expect.

Your body is now coming back into balance. During the first few days after you stop smoking, you might feel edgy and nervous and have trouble concentrating. You might get headaches, feel dizzy and a little out of sorts, feel sweaty or have stomach upsets. You might even have trouble sleeping at first. These are typical withdrawal symptoms that will go away with time. Your smoker’s cough will get worse before it gets better. But don’t worry, that’s a good sign. Coughing helps clear the tar deposits out of your lungs.

After A Week Or Two.

By now you should be feeling more confident that you can handle those smoking urges. Many of your withdrawal symptoms have left by now, and you should be noticing some positives signs: less coughing, better breathing and an improved sense of taste and smell, to name a few.

After A Month.

You probably have the urge to smoke less often now. But urges may still occur, and when they do, they are likely to be powerful ones that come out of nowhere. Don’t let them catch you off guard. Plan ahead for these difficult times.

Concentrate on the ways nonsmokers are more attractive than smokers. Their skin is less likely to wrinkle. Their teeth are whiter, cleaner. Their breath is fresher. Their hair and clothes smell better. That cough that seems to make even a laugh sound more like a rattle is a thing of the past. Their children and others around them are healthier, too.

What To Do About Relapse.

What should you do if you slip and start smoking again? The answer is simple. A lapse of one or two or even a few cigarettes has not spoiled your efforts! Discard your cigarettes, forgive yourself and try again. If you start smoking again, keep your box of Nicotine Polacrilex Gum for your next quit attempt.

If you have taken up regular smoking again, don’t be discouraged. Research shows that the best thing you can do is to try again. The important thing is to learn from your last attempt.

• Admit that you’ve slipped, but don’t treat yourself as a failure.
• Try to identify the “trigger” that caused you to slip, and prepare a better plan for dealing with this problem next time.
• Talk positively to yourself – tell yourself that you have learned something from this experience.
• Make sure you used Nicotine Polacrilex Gum correctly over the full 12 weeks to reduce your craving for nicotine.
• Remember that it takes practice to do anything, and quitting smoking is no exception.

When The Struggle Is Over.

Once you’ve stopped smoking, take a second and pat yourself on your back. Now do it again. You deserve it. Remember now why you decided to stop smoking in the first place. Look at your list of reasons. Read them again. And smile. Now think about all the money you are saving and what you’ll do with it. All the nonsmoking places you can go, and what you might do there. All those years you may have added to your life, and what you’ll do with them. Remember that temptation may not be gone forever. However, the hard part is behind you so look forward with a positive attitude, and enjoy your new life as a nonsmoker.

Questions & Answers.

• 1. How will I feel when I stop smoking and start using Nicotine Polacrilex Gum?

You’ll need to prepare yourself for some nicotine withdrawal symptoms. These begin almost immediately after you stop smoking, and usually at their worst during the first three or four days. Understand that any of the following is possible:

• craving for cigarettes
• anxiety, irritability, restlessness, mood changes, nervousness
• drowsiness
• trouble concentrating
• increased appetite and weight gain
• headaches, muscular pain, constipation, fatigue

Nicotine Polacrilex Gum can help provide relief from withdrawal symptoms such as irritability and nervousness, as well as the craving for nicotine you used to satisfy by having a cigarette.

• 2. Is Nicotine Polacrilex Gum just substituting one form of nicotine for another?

Nicotine Polacrilex Gum does contain nicotine. The purpose of Nicotine Polacrilex Gum is to provide you with enough nicotine to help control the physical withdrawal symptoms so you can deal with the mental aspects of quitting. During the 12 week program, you will gradually reduce your nicotine intake by switching to fewer pieces each day.

• 3. Can I be hurt by using Nicotine Polacrilex Gum?

For most adults, the amount of nicotine in the gum is less than from smoking. Some people will be sensitive to even this amount of nicotine and should not use this product without the advice from their doctor. Check the Some Important Warnings section on the front of this leaflet.

Because Nicotine Polacrilex Gum is a gum-based product, chewing it can cause dental fillings to loosen and aggravate other mouth, tooth, and jaw problems. Nicotine Polacrilex Gum can also cause hiccups, heartburn and other stomach problems especially if chewed too quickly or not chewed correctly.

• 4. Will I gain weight?

Many people do tend to gain a few pounds the first 8 – 10 weeks after they stop smoking. This is a very small price to pay for the enormous gains that you will make in your overall health and attractiveness. If you continue to gain weight after the first two months, try to analyze what you’re doing differently. Reduce your fat intake, choose healthy snacks, and increase your physical activity to burn off the extra calories.

• 5. Is Nicotine Polacrilex Gum more expensive than smoking?

The total cost of Nicotine Polacrilex Gum for the twelve week program is about equal to what a person who smokes one and a half packs of cigarettes a day would spend on cigarettes for the same period of time.

Also, use of Nicotine Polacrilex Gum is only short-term cost, while the cost of smoking is a long-term cost, because of the health problems smoking causes.

• 6. What if I slip up?

Discard your cigarettes, forgive yourself and then get back on track. Don’t consider yourself a failure or punish yourself. In fact, people who have already tried to quit are more likely to be successful the next time.

Good Luck!

: 02952 00 J3

Free Personalized Plan

Begin Right Now!

Having a plan will help you in your efforts to stop smoking. We can help! Follow the simple steps below to receive your valuable personalized Smoke Free Habits plan and many other stop smoking tools and resources.

How To Enroll

Stopping smoking involves breaking your physical addiction and changing your behavior. You will use Nicotine Polacrilex Gum to help break your physical addiction, while your free personalized plan will help you develop healthier behaviors.

To enroll:

• Go online to www.SmokeFreeHabits.com
• Enter the first five digits of the UPC number from the box.
• Answer the questions about yourself.
• Print your personalized plan.

  (If you don’t have access to the internet, you can call 1-866-677-7858, answer questions, and your plan will be mailed to you in a few days.)

What You Will Receive

Here are the free tools and resources that you will receive based on how you sign up for the program:

	Online	By Phone
Personalized 12-Week Plan	immediately	by mail
Buddy Brochure	immediately	by mail
Personal Wellness Assessment	immediately
Week 2 Helpful Tips	X
Week 3 Helpful Tips	X	by mail
Week 4 Helpful Tips	X
Week 6 Helpful Tips	X	by mail
Week 9 Helpful Tips	X
Week 12 Certificate of Accomplishment	X	by mail
Online Drug Database	X
Daily Health News	X

Tips To Get Started

• 1. Follow your personalized Smoke Free Habits support plan.
• 2. Be sure to use Nicotine Polacrilex Gum as directed.
• 3. Throw away all of your cigarettes, lighters, and ashtrays.
• 4. You may feel urges to smoke, but they usually pass in 2-3 minutes. When you feel an urge, do something else. Take deep breaths and let them out slowly. Drink a glass of water.
• 5. Carry things to put in your mouth, like gum, hard candy, or toothpicks.
• 6. Be active, Take a walk with a friend, ride a bike, walk the dog, play tennis.
• 7. Go to places where you are not allowed to smoke, like the movies or the mall. Try to steer clear of places where you usually smoked, like a break room at work or a favorite bar.
• 8. Ask friends or family for support whenever you need it.

Package/Label Principal Display Panel

COMPARE TO NICORETTE® GUM

ACTIVE INGREDIENT

Nicotine Gum

NICOTINE POLACRILEX GUM 2 mg (NICOTINE)

STOP SMOKING AID

Includes User’s Guide

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Gum, 4 mg

actual size

FRUIT WAVE FLAVOR

Coated for BURSTING Flavor

2 mg

100 PIECES

INGREDIENTS AND APPEARANCE

TOPCARE NICOTINE 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-269
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Inactive Ingredients
Ingredient Name	Strength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MANNITOL (UNII: 3OWL53L36A)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score	no score
Shape	RECTANGLE	Size	19mm
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-269-78	100 in 1 CARTON	12/06/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206394	12/06/2019

Labeler - Topco Associates LLC (006935977)

Registrant - L. Perrigo Company (006013346)

Establishment
Name	Address	ID/FEI	Business Operations
Fertin Pharma A/S		307973565	MANUFACTURE(36800-269)