Label: ZONNIC NICOTINE- nicotine gum, chewing

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each chewing piece)

    Nicotine polacrilex (equal to 4 mg nicotine)

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  • Purpose

    Stop smoking aid

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  • Use

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

    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
    oral blistering occurs
    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).
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  • 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 more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
    if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 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.
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  • Other information

    each piece contains: calcium 100 mg and sodium 11 mg
    store at 20-25 oC (68-77 oF)
    protect from light
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  • Inactive ingredients

    acacia, acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, gum base, maltitol, menthol, natural and artificial cinnamon and mint flavors, polysorbate 60, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sucralose, talc, titanium dioxide

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  • Questions or comments?

    call 1-866-677-7858

    Consumer Information

    ZONNIC®

    NICOTINE POLACRILEX GUM

    2mg AND 4mg USER’S GUIDE

    GUM

    HOW TO USE ZONNIC 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 Zonnic Gum to help you.

    2. You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Zonnic Gum. See chart on back side of leaflet.

    3. You should continue to use Zonnic Gum as explained in this User’s Guide for 12 full weeks. If you feel you need to use Zonnic Gum for a longer period to keep from smoking, talk to your health care provider.

    4. Zonnic 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 Zonnic 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 in choosing Zonnic 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 Zonnic Gum.

    Zonnic Nicotine Hands

    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 Zonnic Gum and give 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 Zonnic Gum with a support program that helps you 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 Zonnic 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 Zonnic 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 effect 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 this 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 nicotine has become both physical and mental. You must overcome both addictions to stop smoking. So while Zonnic 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 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

    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 the 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 bought the right starting dose. If you smoke your first cigarette within 30 minutes of waking up, use Zonnic Gum, 4 mg. If you smoke your first cigarette more than 30 minutes after waking up, use Zonnic 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 Zonnic Gum).

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

    STEP 2. (Weeks 7-9).

    The day you’ll start reducing your use of Zonnic Gum.

    After six weeks, you’ll begin gradually reducing your Zonnic 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 your use of Zonnic Gum.

    Nine weeks after you begin using Zonnic 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 Zonnic Gum every four to eight hours.

    End of treatment:

    The day you’ll complete Zonnic Gum therapy.

    Identify the date thirteen weeks after the date you chose 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 Zonnic 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 Zonnic 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 ZONNIC GUM WORKS.

    Zonnic Gum’s sugar-free chewing pieces provide nicotine to your system - they work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms. Zonnic 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 Zonnic 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 headache, nausea, upset stomach, and dizziness.

    HOW TO USE ZONNIC GUM.

    If you are under 18 years of age, ask a doctor before use.

    Before you can use Zonnic Gum correctly, you have to practice! That sounds silly, but it isn’t. Zonnic 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, Zonnic Gum won’t work well and can cause side effects. An overdose can occur if you chew more than one piece of Zonnic Gum at the same time, or if you chew many pieces one after another. Read all the following instructions before using Zonnic Gum. Refer to them often to make sure you’re using Zonnic 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 Zonnic Gum, or while chewing a piece. The effectiveness of Zonnic Gum may be reduced by some foods and drinks, such as coffee, juices, wine or soft drinks.

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

    The following chart lists the recommended

    usage schedule for Zonnic 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 Zonnic 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 ZONNIC GUM USAGE.

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

    After a while, start chewing each Zonnic 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 Zonnic Gum pieces you would normally use. Increase the number of pieces of ordinary gum as you cut back on the Zonnic Gum pieces.
    Check how well you’ve reduced your daily usage of Zonnic 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 Zonnic Gum when you have completed treatment.

    Set a stop date.
    Use the same number of pieces of confectionery gum or mints as you were using Zonnic Gum per day. At the times when you have an urge to use Zonnic 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 Zonnic Gum at the end of week 12 to keep from smoking
    start using Zonnic 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 Date:

    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 Zonnic 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 a 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.
    Zonnic Nicotine Bike

    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 positive 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 much 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.

    Zonnic Nicotine Calendar

    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 Zonnic 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 Zonnic 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 AND ANSWERS.

    1. How will I feel when I stop smoking and start using Zonnic Gum?

    You’ll need to prepare yourself for some nicotine withdrawal symptoms. These begin almost immediately after you stop smoking, and are 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

    Zonnic 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 Zonnic Gum just substituting one form of nicotine for another?

    Zonnic Gum does contain nicotine. The purpose of Zonnic 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 Zonnic 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 advice from their doctor. Check the SOME IMPORTANT WARNINGS section on the front of this leaflet.

    Because Zonnic Gum is a gum-based product, chewing it can cause dental fillings to loosen and aggravate other mouth, tooth and jaw problems. Zonnic 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 Zonnic Gum more expensive than smoking?

    The total cost of Zonnic 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 Zonnic Gum is only a 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.

    Zonnic Nicotine Flag

    GOOD LUCK!

    RECOMMENDED DOSAGE SCHEDULE FORZONNIC GUM

    STEP 1

    STEP 2

    STEP 3

    Weeks 1 to 6

    1 piece every

    1 to 2 hours

    Weeks 7 to 9

    1 piece every

    2 to 4 hours

    Weeks 10 to 12

    1 piece every

    4 to 8 hours

    MADE IN DENMARK

    DISTRIBUTED BY NICONOVUM USA

    WINSTON-SALEM, NC 27101

    FREE PERSONALIZED PLAN

    Smoke Free Habits Logo

    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 Zonnic 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.
    Example UPC

    (If you don’t have access to the internet, you can call 1-866-677-7858, answer questions, and your plan will be amiled 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 Zonnic 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 your 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.
    Zonnic Reminders
    Zonnic Wallet Card
    Zonnic Wallet Card
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  • Principal Display Panel

    NEW DIRECTIONS FOR USE

    Keep using if you slip up and have a cigarette

    Use beyond 12 weeks if needed to quit

    CINNAMON

    4mg

    ZONNIC

    NICOTINE POLACRILEX GUM, 4mg (NICOTINE)

    STOP SMOKING AID

    FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP. IF YOU SMOKE YOUR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP, USE ZONIE 2mg.

    10 COATED PIECES*, 4mg EACH

    *This package size may not be a full day’s supply; it is intended to start or continue a quit attempt.

    Zonnic Nicotine Polacrilex Gum Image 1
    Zonnic Nicotine Polacrilex Gum Image 2
    Zonnic Nicotine Polacrilex Gum Image 3
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  • INGREDIENTS AND APPEARANCE
    ZONNIC NICOTINE 
    nicotine polacrilex gum, chewing
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42884-442
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    ACACIA  
    D&C YELLOW NO. 10  
    MALTITOL  
    POLYSORBATE 60  
    SODIUM BICARBONATE  
    SODIUM CARBONATE  
    SORBITOL  
    SUCRALOSE  
    TALC  
    TITANIUM DIOXIDE  
    MENTHOL  
    POLACRILIN  
    Product Characteristics
    Color YELLOW (light yellow) Score no score
    Shape RECTANGLE Size 16mm
    Flavor CINNAMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42884-442-52 10 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091354 05/03/2013
    Labeler - Niconovum USA Inc. (962196684)
    Close