SPL UNCLASSIFIED SECTION.


Consumer Information. Nicotine Polacrilex Lozenge2 mg and mg Users GuideHow to Use Nicotine Polacrilex Lozenges and Tips to Help You Quit Smoking.oNot for sale to those under 18 years of ageoProof of age requiredoNot for sale in vending machines or from any source where proof of age cannot be verifiedPLANNING YOUR SUCCESS1)The key to accomplishing anything important is commitment. When it comes to quitting smoking, that is especially true. Nicotine Polacrilex Lozenges can help if you really want to quit. Nicotine Polacrilex Lozenges help reduce withdrawal symptoms including nicotine craving associated with quitting smoking.2)Your chances of staying off cigarettes are much better if you start with at least Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on regular schedule (as outlined in this Users Guide).3)Start using Nicotine Polacrilex Lozenges on your quit date.4)This Users Guide outlines 12-week plan for Nicotine Polacrilex Lozenges. Even though you may feel confident about your non-smoking status after few weeks, its important to stick with the plan to help you remain smoke free. Even single cigarette can put you right back to square one.5)Nicotine Polacrilex Lozenges work best when used together with support plan. See information to the right for instructions on enrollment in the SmokeFreeHabits.com Free Personalized Support Plan.6)After the first six weeks, start using fewer Nicotine Polacrilex Lozenges, as directed in the instructions, gradually reducing your use over the next six weeks. If you feel the need to use the lozenges for longer period to keep from smoking, talk to your health care provider.7)If you have questions about using Nicotine Polacrilex Lozenges, please talk to your pharmacist, family doctor, or call toll-free 1-866-751-9303.YES YOU WANT TO QUIT.Wonderful. Youve made the most important decision of all, to stop smoking. And by choosing Nicotine Polacrilex Lozenges to help you, youre starting on the right path. Now remember, using Nicotine Polacrilex Lozenges doesnt just mean taking Nicotine Polacrilex Lozenge. It means setting and following program like the one we suggest in this Users Guide.Your own success depends on your effort, your level of addiction to tobacco, and your commitment to following your program.LETS FACE IT.Quitting smoking isnt easy You or someone you know may have tried unsuccessfully. Thats okay. Its hard to stop smoking the first time you try. The important part is to learn from your previous attempts, consider what went wrong and keep trying to quit until you succeed. Look to this Users Guide for support as you undergo this terrific task. The guide includes important information on how to use Nicotine Polacrilex Lozenges and also gives you tips to help you stop smoking. Refer back to it often for advice, answers, and encouragement to help you stay on track.GET MOTIVATED. STAY MOTIVATED.Everyone has reason for quitting-whether youre concerned about your health, your appearance, family or peer pressure, or the effect of secondhand smoke on your loved ones-all of the above, or something else entirely. Whatever your reasons, write them down. Theres wallet card on the bottom of this Users Guide. Write your reasons on the card and carry it with you. When you have an urge to smoke or experience difficult moment it can help you focus on your reasons for quitting. Lots of people quit with co-worker, spouse or friend and use them as quitting buddy. You can help each other out by providing extra encouragement in tough moments.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 Users Guide.UNDERSTANDING THE DOUBLE-EDGED SWORD.Smoking has two addictive components, physical and mental need for the nicotine in tobacco. You need to conquer both to succeed. Nicotine Polacrilex Lozenges can ease your physical nicotine addiction. But your readiness and resolve are necessary to help overcome the mental side of your cigarette dependence. So once youre ready, its time to begin. But first, read and consider the following important warnings.IMPORTANT WARNINGSThis 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 doctor before use if you haveoa sodium-restricted dietoheart disease, recent heart attack or irregular heartbeat. Nicotine can increase your heart rate.ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.ostomach ulcers or diabetes.ohistory of seizuresAsk doctor or pharmacist before use if you areousing non-nicotine stop smoking drugotaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.Stop use and ask doctor ifomouth problems occuropersistent indigestion or severe sore throat occursoirregular heartbeat or palpitations occuroyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeatoyou have symptoms of an allergic reaction (such as difficulty breathing or rash)Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)YOURE READY TO START.Okay, youre ready. To become non-smoker, start today. Now before you do anything else, you have bit of planning to do. Read this Users Guide all the way through. You want to make sure you bought the right dose to start. If you typically smoke your first cigarette within 30 minutes of waking up, use the mg Nicotine Polacrilex Lozenges. If you smoke your first cigarette more than 30 minutes after waking up, use the mg Nicotine Polacrilex Lozenges.Next, plan your quitting schedule. Get calendar to follow your progress and mark the following four important dates (see the reminders on the left side of this leaflet).THE PROGRAMSTEP 1. (Weeks 1-6) Starting on your quit date its best to use at least Nicotine Polacrilex Lozenges each day, one every 1-2 hours.First choose the day you plan to quit (make it soon). Place the Step reminder on this date. Thats the day you will start using Nicotine Polacrilex Lozenges to calm your cravings for nicotine and help you stay smoke free. Prior to the quit date, get rid of all your cigarettes to remove temptations and make it more difficult to start smoking again.Use Nicotine Polacrilex Lozenge every to hours and at least lozenges each day for the first weeks to help prevent unexpected cravings and improve your chances of quitting. These arent ordinary lozenges. Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow the lozenge. You may feel warm or tingling sensation. Occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 to 30 minutes). Remember to read the USING Nicotine Polacrilex LOZENGES PROPERLY section before you take your first Nicotine Polacrilex Lozenge. STEP 2. (The next three weeks, that is weeks 7-9). At the beginning of week start using fewer Nicotine Polacrilex Lozenges, one every 2-4 hours.After six weeks, you should wait little longer between lozenges, one lozenge every two to four hours. This will help you gradually use fewer Nicotine Polacrilex Lozenges. Put the Step reminder on the first day of week to help remind you when to start reducing the number of Nicotine Polacrilex Lozenges you take.STEP 3. (The last three weeks, that is weeks 10-12). At the beginning of week 10, reduce Nicotine Polacrilex Lozenge use even further, one every 4-8 hours.At the beginning of week 10 further decrease the number of Nicotine Polacrilex Lozenges you use each day to reduce the amount of nicotine you get. You should do this by using one lozenge every to hours. Put the Step reminder on the first day of week 10 so you know when you should be starting this last step to becoming smoke and nicotine-free.END. At the end of week 12 youll complete Nicotine Polacrilex Lozenges therapy.Put the EX-SMOKER reminder on your calendar on the date 12 weeks after the day you stopped smoking and started using Nicotine Polacrilex Lozenges.BE PREPARED.Since smoking is an addiction, it is hard to quit. Even after you stop, there will be times when you WANT cigarette, sometimes strongly. (See also section on Challenges To Watch For). The best defense is to be prepared. Plan now for handling tough times so you dont give in. For example: think about situations when you usually get craving for cigarettes or where you think you might experience strong cravings. Try to avoid these situations where you can (for example, avoid spending time with smokers, or drinking alcohol, if those things tempt you to smoke). Change your habits. For example, take your coffee break somewhere else. Take walk. In other words, break the association between your usual habits and cigarettes. If you do encounter situation where you feel strong craving, fight it Take break from the situation; keep yourself busy or distracted with other activities. Remind yourself why you want to quit, and above all, remind yourself that having just one really will hurt your goal of quittingTo prepare for tough situations, assemble survival package texts that can keep you distracted in case you get craving. For example, you may include cinnamon gum or hard candy, relaxing music, and things to keep your hands busy like smooth stone, paper clips, or rubber ball.Track your progress as you quit. Keep journal. Write down how many pieces of Nicotine Polacrilex Lozenges you use each day. Note if and when you get craving. If you slip and have cigarette, dont give up. Stop smoking again and get back on your program with Nicotine Polacrilex Lozenges.Establish your support network. Keep friends and family members phone numbers ready to get the moral support you need. Before quitting, ask friends and family to support and encourage you. Think of specific ways they can help.Reward yourself. Set aside little gifts to yourself such as CD or video, which you can earn by overcoming difficult hurdles.HOW Nicotine Polacrilex LOZENGES WORK.Nicotine Polacrilex Lozenges are form of Nicotine Replacement Therapy. They deliver nicotine to your body, temporarily relieving craving and nicotine withdrawal symptoms when you quit smoking. But unlike cigarettes, Nicotine Polacrilex Lozenges deliver lower, steady level of nicotine to your blood. When used as directed, Nicotine Polacrilex Lozenges help you regulate, control, and gradually reduce your bodys craving for nicotine. The good news is that Nicotine Polacrilex Lozenges contain no tar or carbon monoxide, and therefore dont present the same medical risks as cigarettes.However, the lozenges still deliver nicotine, the addictive ingredient in cigarettes. And for some people the nicotine in Nicotine Polacrilex Lozenges can occasionally cause mouth or throat irritation, headaches, nausea, hiccups, upset stomach or dizziness.USING Nicotine Polacrilex LOZENGES PROPERLY.Remember, Nicotine Polacrilex Lozenges arent like ordinary lozenges such as cough drops. This lozenge is designed to deliver nicotine into your system through the lining of your mouth, not in your stomach like most other medicines. It is important to minimize swallowing the dissolved medicine in these lozenges so that it can be properly absorbed in your mouth.Do not use more than one lozenge at time, or many lozenges one after another since this can cause hiccups, heartburn, nausea or other side effects.Read all the following instructions before using Nicotine Polacrilex Lozenges. Refer to them often to make sure youre using Nicotine Polacrilex Lozenges correctly.IMPORTANT: Dont worry or give up if you do not like the taste of the lozenge at first. Nicotine Polacrilex Lozenges are medication, not candy. Most people get used to the taste after day or two. Remember, staying with the plan will help you quit. Begin using Nicotine Polacrilex Lozenges on your quit date.1)Remove the Nicotine Polacrilex Lozenge from the immediate container. Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow the lozenge. You may feel warm or tingling sensation.2)Occasionally move the lozenge from one side of your mouth to the other side until completely dissolved (about 20-30 minutes).To reduce cravings or urges to smoke and other withdrawal symptoms, use Nicotine Polacrilex Lozenges according to the following dosage schedule.Weeks through 6Weeks through 9Weeks 10 through 121 lozenge every to hours1 lozenge every to hours1 lozenge every to hoursDo not use more than lozenges in hours. Do not use more than 20 lozenges per day. At the end of 12 weeks (3 months) you will have completed treatment.FOR THE BEST CHANCE OF QUITTING, use Nicotine Polacrilex Lozenges on regular schedule, using at least lozenges day during the first weeks. That will help your body better adjust to the lack of cigarettes and better help prevent cravings. Some people may need more lozenges to reduce their cravings. Do not exceed the recommended maximum daily dosage of 20 lozenges per day. Do not continuously use one lozenge after another, since this may cause you hiccups, heartburn, nausea or other side effects.Do not eat or drink 15 minutes before using or while the lozenge is in your mouth.CUTTING BACK ON YOUR Nicotine Polacrilex LOZENGE USAGE.The whole reason for using Nicotine Polacrilex Lozenges is to decrease and slowly eliminate your need for nicotine, while you control cravings. So, as the above schedule indicates, you should gradually reduce the amount of Nicotine Polacrilex Lozenges you take per day. Some people find it easier to reduce by substituting ordinary sweets or sugar free candy for some of the Nicotine Polacrilex Lozenges they would normally use. As time goes on, you can increase the number of pieces of candy as you further reduce your use of Nicotine Polacrilex Lozenges. It is important to complete treatment. If you still feel the need to use Nicotine Polacrilex Lozenges to keep from smoking after week 12, talk with your health care provider.MAKE QUITTING EASIER ON YOURSELF.Soon after your quit date, parties, bars, celebrations, and socializing may all tempt you to smoke. Please remember these tips to help you resist those urges and stay smoke-free.The Day You Quit Smoking:oLook to your family and friends for support. Let them know what to do or avoid doing to help you quit.oThrow away ALL cigarettes, ashtrays, matches, lighters. You dont need them. You dont want them and you want to make it difficult to go back.oKeep yourself occupied. Take walk. See movie. See friends. Do anything to keep your mind off cigarettes.oCalculate all the money youll save by not buying cigarettes. Probably well over 1,000 year 1,000 year Think of what you can spend it onoKnow what situations are going to make you want to smoke. Plan now how youll avoid them or deal with them so you dont smoke.oKeep Nicotine Polacrilex Lozenges next to your bed so youre prepared when you get up. lot of people get cravings first thing in the morning.oMake an appointment to see your dentist and get the tobacco stains cleaned off. While youre getting rid of the evidence of cigarettes in the house, do the same for your teeth. Have clothes or drapes that smell of smoking cleaned.oNow that your house is smoke-free, try to spend most of your time in smoke-free environments.oIf you usually smoked with coffee or alcohol, try to keep away from them for now. Remember you are also trying to break habit.oSmoking is hands-on habit. So use something else to occupy your hands: rubber band or pen.oNows good time to get active. Find activities to take your mind off cigarettes and relax. Take up jogging, swimming, or walking.oDont stress out about gaining weight. Dieting now may weaken your efforts to quit smoking. Eat sensibly and exercise daily; drink large quantities of water and fruit juices; this can help your chances of staying smoke-free.oLaugh. Watch sitcom. Read comic book. It really helps.REMEMBER: Urges to smoke are temporary. Theyll pass, even if you dont smoke.WHAT YOU CAN EXPECT.As you are successful at staying smoke-free, initially you will probably notice few of the following typical withdrawal symptoms, so dont be surprised. Use of Nicotine Polacrilex Lozenges reduces these symptoms, but may not eliminate them entirely. They will go away with time. Stay focused on your goal of becoming an ex-smoker. Research shows that if you manage to avoid all smoking in the first week (that means not having single puff), your chances of success increase dramatically.The First Few Days. You may feel nervous or irritable or have difficulty concentrating during the first few days after you quit smoking. Your body needs time to regain balance. Initially, you might feel little out of sorts, get headaches, feel light-headed, or have trouble sleeping. Your smokers cough may get worse before it improves. But fear not, its positive sign. Coughing helps clean your lungs of the tar residue you got from smoking.After Couple of Weeks. Your confidence and ability to cope with urges to smoke should be getting stronger. But dont be over-confident and think you can smoke just one cigarette. Even now, having even single puff can lead to return to smoking cigarettes regularly. Be prepared, and remember why you wanted to stop smoking.Have you noticed that your sense of taste and smell has improved You are probably coughing less and finding it easier to breathe. Youve also probably noticed your withdrawal symptoms are subsiding (though dont worry if theyre still there: they last longer for some people). These are all positive signs that your body is getting used to your success at stopping smoking.By The End of The First Month. You are less likely to have cravings for cigarettes as often. However sudden cravings may still happen, and when they do, be on your guard, as they can be strong and seem to come out of the blue. Be prepared for these challenging times. The key is do what you can so these unexpected cravings cant beat you. Keep focused on the ways non-smokers are more attractive than smokers. Their breath smells better. Their clothes and hair are fresher. Their teeth are cleaner and brighter. Their skin is less likely to wrinkle. Not smoking around children and your friends is also healthier for them too.What If You Do Slip And SmokeWhat if relapse One cigarette is slip-up, but its not the end of the quit effort. Everybody slips at something. The key is this: forgive yourself and stop at that one cigarette. Dont let this slip ruin your good intentions, keep at your quit attempt. So, throw out your cigarettes and continue with your quit attempt, keeping in mind what went wrong and led to the slip.If you do go back to smoking, certainly dont throw out your Nicotine Polacrilex Lozenges. Keep them for the next time youre ready to quit. In fact research says that even if you are back to smoking regularly the best thing you can do is learn and try again.Try to understand the reason you had those cigarettes that made you slip. Thats important, because now you can plan better to deal with these moments next time. Its true you stumbled, but dont think of yourself as having failed. Encourage yourself by treating the last attempt as learning experience, even trial run for the real thing.Take look at the usage instructions and check that you used the Nicotine Polacrilex Lozenges correctly and for the full 12 weeks of the program. When you try again make sure you use enough and the right way. That way youll be best equipped to deal with the unexpected cravings.Dont forget; quitting isnt easy and it takes practice to do anything. Stopping smoking is no different.YOUVE MADE IT.Once your twelve week quitting program is over, youve taken your last Nicotine Polacrilex Lozenge. Now you are both cigarette and nicotine-free. Get up and give yourself standing ovation. We mean it. Do you realize that you have just done really difficult thingNows good time to think back on the process. Think of all your reasons for quitting smoking. Think of your goals. Think of how theyre going to be reality now.Think of what youre going to do with your newly liberated cigarette money. The places you can now go smoke-free. Think of the extra time you may have added to your life and what you can do with it. And although you may still experience the occasional temptation, and cigarettes still want you back, think positively. Think forward. And consider yourself proud non-smoker.FREQUENTLY ASKED QUESTIONS.1. When stop smoking and start using Nicotine Polacrilex Lozenges how will feelNicotine Polacrilex Lozenges help reduce cravings, but be prepared for some nicotine withdrawal symptoms. After you stop smoking they can begin almost at once and are normally at their strongest during the first three or four days. For some people, any of the following may occur:ounexpected craving or urges for cigarettesoanxiety, irritability, restlessness, mood changes, nervousnessodrowsinessotrouble concentratingoincreased appetite and weight gainoheadaches, muscular pain, constipation, fatigueNicotine Polacrilex Lozenges are designed to reduce the craving for nicotine you used to satisfy with cigarettes. Nicotine Polacrilex Lozenges can also help provide relief from other withdrawal symptoms such as irritability and nervousness.2. Are Nicotine Polacrilex Lozenges just swapping one type of nicotine addiction for anotherNicotine Polacrilex Lozenges do contain nicotine, however there is probably less nicotine in your daily dose of lozenges than in your cigarettes. Nicotine Polacrilex Lozenges give you enough nicotine to help you combat the physical withdrawal symptoms so you can cope with the mental side of stopping smoking. Also, since the nicotine from the lozenges goes into your bloodstream more slowly, it produces less of the effects of nicotine that people find rewarding. In fact, when used as directed in the 12 week program, Nicotine Polacrilex Lozenges gradually wean you off your dependence for both nicotine and cigarettes.3. Can Nicotine Polacrilex Lozenges do any harmSome people with conditions like heart disease or people taking prescription medicine for asthma or depression should not use this product without talking to their doctor check the IMPORTANT WARNINGS on the front of this leaflet. You may also experience side effects such as hiccups, mouth or throat irritation, heartburn or other stomach problems such as nausea especially if Nicotine Polacrilex Lozenges are chewed or swallowed. In any case, Nicotine Polacrilex Lozenges do not contain the tar, carbon monoxide, and other toxins present in cigarette smoke.4. Will put on weightIn the first couple of months after quitting smoking, some people do put on few pounds. But think of it this way. Overall, youll be healthier and look better. You can always tackle your weight by changing your diet and increasing the amount you exercise once you have gotten through the difficult part of stopping smoking.5. Does taking Nicotine Polacrilex Lozenges cost more than smokingIf you normally smoke pack and half day, your total cost of using Nicotine Polacrilex Lozenges during the 12-week period should be less than smoking. But guess what After youve finished the Nicotine Polacrilex Lozenge program all that money you used to spend on cigarettes is now savings. And think of the health issues youll hopefully be able to avoid.6. What if have cigarette and start smokingDont panic. First, dont think badly of yourself. Throw away your cigarettes and forgive yourself. Then think about what went wrong and get back on track. In fact people who have already tried to stop smoking are more likely to be successful the next time.CHALLENGES TO WATCH FOR.Once you quit smoking, you are likely to experience periodic, and sometimes intense, temptations to smoke. Certain situations present special challenges. Some common ones include:Stress and upset.When you are feeling stressed or upset, you may think cigarette will make everything better. It wont. Find other ways to relax and unwind.The blues.You may be especially vulnerable when you feel bored or blue. Remember that having cigarette will just make you feel worse.Smoking cues.Seeing cigarettes or watching other people smoke can trigger temptation. Remember that you choose not to smoke anymore.Alcohol.Drinking and smoking seem to go together, and alcoholic beverages may weaken your resolve, making drinking dangerous to your quit effort. Avoid drinking early in your quit effort, and try to drink with non-smokers.Automatic slips.Sometimes you may find yourself preparing to smoke without even realizing it. Watch out for those moments when your hand seems to automatically reach for cigarette.Watch out for these situations: they can trigger relapse. You probably know which one(s) are most dangerous for you; plan ahead to deal with the situation effectively. Always remember that youre trying to break habit, and the most important thing is to do something to combat the urge in these situations.COPING AFTER QUITTING.The key to staying smoke-free is to prepare for and cope with challenges as they occur. If you find yourself tempted to smoke, do something Here are some things to consider.oEscape. Leave the situation, even for few minutes. Most temptations dont last long.oDistract yourself. Get your mind off smoking. Think of something else or get busy with something.oRelax. Dont let stress get to you. Think of pleasant, relaxing things; breathe slowly and regularly. Let the stress drain out of you.oTalk yourself out of it. What you say to yourself matters. So, remind yourself how important it is for you to quit; remind yourself you cant have just one; or just command yourself to STOP.For more information please visit www.SmokeFreeHabits.comFree Personalized PlanBegin Right NowHaving 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 EnrollStopping smoking involves breaking your physical addiction and changing your behavior. You will use Nicotine Polacrilex Lozenges to help break your physical addiction, while your free personalized plan will help you develop healthier behaviors.To enroll:oGo online to www.SmokeFreeHabits.comoEnter the first five digits of the UPC number from the box.oAnswer the questions about yourself.oPrint your personalized plan.(If you dont have access to the Internet, you can call 1-866-751-9303, answer questions, and your plan will be mailed to you in few days.)What You Will ReceiveHere are the free tools and resources that you will receive based on how you sign up for the program:OnlineBy PhonePersonalized 12-Week Planimmediatelyby mailBuddy Brochureimmediatelyby mailPersonal Wellness AssessmentimmediatelyWeek Helpful TipsXWeek Helpful TipsXby mailWeek Helpful TipsXWeek Helpful TipsXby mailWeek Helpful TipsXWeek 12 Certificate of AccomplishmentXby mailOnline Drug DatabaseXDaily Health NewsXTips To Get Started1.Follow your personalized Smoke Free Habits support plan.2.Be sure to use Nicotine Polacrilex Lozenges 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 glass of water.5.Carry things to put in your mouth, like gum, hard candy or toothpicks.6.Be active. Take walk with 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 break room at work or favorite bar.8.Ask friends or family for support whenever you need it.Packaged ByPerrigo(R)Allegan, MI 49010: 87300 00 J2. oNot for sale to those under 18 years of age. oProof of age required. oNot for sale in vending machines or from any source where proof of age cannot be verified. 1)The key to accomplishing anything important is commitment. When it comes to quitting smoking, that is especially true. Nicotine Polacrilex Lozenges can help if you really want to quit. Nicotine Polacrilex Lozenges help reduce withdrawal symptoms including nicotine craving associated with quitting smoking.. 2)Your chances of staying off cigarettes are much better if you start with at least Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on regular schedule (as outlined in this Users Guide).. 3)Start using Nicotine Polacrilex Lozenges on your quit date.. 4)This Users Guide outlines 12-week plan for Nicotine Polacrilex Lozenges. Even though you may feel confident about your non-smoking status after few weeks, its important to stick with the plan to help you remain smoke free. Even single cigarette can put you right back to square one.. 5)Nicotine Polacrilex Lozenges work best when used together with support plan. See information to the right for instructions on enrollment in the SmokeFreeHabits.com Free Personalized Support Plan.. 6)After the first six weeks, start using fewer Nicotine Polacrilex Lozenges, as directed in the instructions, gradually reducing your use over the next six weeks. If you feel the need to use the lozenges for longer period to keep from smoking, talk to your health care provider.. 7)If you have questions about using Nicotine Polacrilex Lozenges, please talk to your pharmacist, family doctor, or call toll-free 1-866-751-9303.. oa sodium-restricted diet. oheart disease, recent heart attack or irregular heartbeat. Nicotine can increase your heart rate.. ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.. ostomach ulcers or diabetes.. ohistory of seizures. ousing non-nicotine stop smoking drug. otaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.. omouth problems occur. opersistent indigestion or severe sore throat occurs. oirregular heartbeat or palpitations occur. oyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat. oyou have symptoms of an allergic reaction (such as difficulty breathing or rash). 1)Remove the Nicotine Polacrilex Lozenge from the immediate container. Place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow the lozenge. You may feel warm or tingling sensation.. 2)Occasionally move the lozenge from one side of your mouth to the other side until completely dissolved (about 20-30 minutes).To reduce cravings or urges to smoke and other withdrawal symptoms, use Nicotine Polacrilex Lozenges according to the following dosage schedule.. oLook to your family and friends for support. Let them know what to do or avoid doing to help you quit.. oThrow away ALL cigarettes, ashtrays, matches, lighters. You dont need them. You dont want them and you want to make it difficult to go back.. oKeep yourself occupied. Take walk. See movie. See friends. Do anything to keep your mind off cigarettes.. oCalculate all the money youll save by not buying cigarettes. Probably well over 1,000 year 1,000 year Think of what you can spend it on. oKnow what situations are going to make you want to smoke. Plan now how youll avoid them or deal with them so you dont smoke.. oKeep Nicotine Polacrilex Lozenges next to your bed so youre prepared when you get up. lot of people get cravings first thing in the morning.. oMake an appointment to see your dentist and get the tobacco stains cleaned off. While youre getting rid of the evidence of cigarettes in the house, do the same for your teeth. Have clothes or drapes that smell of smoking cleaned.. oNow that your house is smoke-free, try to spend most of your time in smoke-free environments.. oIf you usually smoked with coffee or alcohol, try to keep away from them for now. Remember you are also trying to break habit.. oSmoking is hands-on habit. So use something else to occupy your hands: rubber band or pen.. oNows good time to get active. Find activities to take your mind off cigarettes and relax. Take up jogging, swimming, or walking.. oDont stress out about gaining weight. Dieting now may weaken your efforts to quit smoking. Eat sensibly and exercise daily; drink large quantities of water and fruit juices; this can help your chances of staying smoke-free.. oLaugh. Watch sitcom. Read comic book. It really helps.. ounexpected craving or urges for cigarettes. oanxiety, irritability, restlessness, mood changes, nervousness. odrowsiness. otrouble concentrating. oincreased appetite and weight gain. oheadaches, muscular pain, constipation, fatigue. oEscape. Leave the situation, even for few minutes. Most temptations dont last long.. oDistract yourself. Get your mind off smoking. Think of something else or get busy with something.. oRelax. Dont let stress get to you. Think of pleasant, relaxing things; breathe slowly and regularly. Let the stress drain out of you.. oTalk yourself out of it. What you say to yourself matters. So, remind yourself how important it is for you to quit; remind yourself you cant have just one; or just command yourself to STOP.. oGo online to www.SmokeFreeHabits.com. oEnter the first five digits of the UPC number from the box.. oAnswer the questions about yourself.. oPrint your personalized plan.. 1.Follow your personalized Smoke Free Habits support plan.. 2.Be sure to use Nicotine Polacrilex Lozenges 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 glass of water.. 5.Carry things to put in your mouth, like gum, hard candy or toothpicks.. 6.Be active. Take walk with 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 break room at work or favorite bar.. 8.Ask friends or family for support whenever you need it.. Wallet Card. Wallet Card. Smoke Free Logo. UPC Example. Reminder Stickers.

DOSAGE & ADMINISTRATION SECTION.


Directions. oif you are under 18 years of age, ask doctor before use. No studies have been done to show if this product will work for you.obefore using this product, read the enclosed Users Guide for complete directions and other important informationobegin using the lozenge on your quit dayoif you smoke your first cigarette more than 30 minutes after waking up, use mg nicotine lozengeoif you smoke your first cigarette within 30 minutes of waking up, use mg nicotine lozenge according to the following 12 week schedule:Weeks to 6Weeks to 9Weeks 10 to 121 lozenge every1 to hours1 lozenge every2 to hours1 lozenge every4 to hoursonicotine lozenge is medicine and must be used certain way to get the best resultsoplace the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.oyou may feel warm or tingling sensationooccasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)odo not eat or drink 15 minutes before using or while the lozenge is in your mouthoto improve your chances of quitting, use at least lozenges per day for the first weeksodo not use more than one lozenge at time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effectsodo not use more than lozenges in hours. Do not use more than 20 lozenges per day.oit is important to complete treatment. If you feel you need to use the lozenge for longer period to keep from smoking, talk to your health care provider.. oif you are under 18 years of age, ask doctor before use. No studies have been done to show if this product will work for you.. obefore using this product, read the enclosed Users Guide for complete directions and other important information. obegin using the lozenge on your quit day. oif you smoke your first cigarette more than 30 minutes after waking up, use mg nicotine lozenge. oif you smoke your first cigarette within 30 minutes of waking up, use mg nicotine lozenge according to the following 12 week schedule:. onicotine lozenge is medicine and must be used certain way to get the best results. oplace the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.. oyou may feel warm or tingling sensation. ooccasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes). odo not eat or drink 15 minutes before using or while the lozenge is in your mouth. oto improve your chances of quitting, use at least lozenges per day for the first weeks. odo not use more than one lozenge at time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects. odo not use more than lozenges in hours. Do not use more than 20 lozenges per day.. oit is important to complete treatment. If you feel you need to use the lozenge for longer period to keep from smoking, talk to your health care provider.

INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. acesulfame potassium, magnesium stearate, mannitol, natural and artificial cherry flavor, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum.

INDICATIONS & USAGE SECTION.


Use. oreduces withdrawal symptoms, including nicotine craving, associated with quitting smoking. oreduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each lozenge). Nicotine polacrilex, mg (nicotine).

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. oa sodium-restricted dietoheart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.ostomach ulcer or diabetesohistory of seizures. oa sodium-restricted diet. oheart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.. ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.. ostomach ulcer or diabetes. ohistory of seizures.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. ousing non-nicotine stop smoking drugotaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.. ousing non-nicotine stop smoking drug. otaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children and pets.. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222).

OTC - PREGNULLNCY OR BREAST FEEDING SECTION.


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.

OTC - PURPOSE SECTION.


Purpose. Stop smoking aid.

OTC - QUESTIONS SECTION.


Questions or comments. call toll-free 1-866-751-9303.

OTC - STOP USE SECTION.


Stop use and ask doctor if. omouth problems occuropersistent indigestion or severe sore throat occursoirregular heartbeat or palpitations occuroyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeatoyou have symptoms of an allergic reaction (such as difficulty breathing or rash). omouth problems occur. opersistent indigestion or severe sore throat occurs. oirregular heartbeat or palpitations occur. oyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat. oyou have symptoms of an allergic reaction (such as difficulty breathing or rash).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel. mgCompare to Nicorette(R) Lozenge active ingredientnicotine lozengeNicotine Polacrilex Lozenge mg (nicotine)Stop Smoking AidFOR 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 Nicotine Polacrilex Lozenge, mg.Cherry Flavoractual size72 LOZENGES, mg EACH(3 QuitTube(R) Containers of 24)Includes Users Guide. 190-an-nicotine-lozenge-1.jpg. 190-an-nicotine-lozenge-2.jpg.

STORAGE AND HANDLING SECTION.


Other information. oeach lozenge contains: sodium 17 mgosugar alcohol content: g mannitol per lozengeostore at 20-25C (68-77F)okeep vial tightly closed and protect from light. oeach lozenge contains: sodium 17 mg. osugar alcohol content: g mannitol per lozenge. ostore at 20-25C (68-77F). okeep vial tightly closed and protect from light.

WARNINGS SECTION.


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 doctor before use if you have. oa sodium-restricted dietoheart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.ostomach ulcer or diabetesohistory of seizures. oa sodium-restricted diet. oheart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.. ohigh blood pressure not controlled with medication. Nicotine can increase your blood pressure.. ostomach ulcer or diabetes. ohistory of seizures. Ask doctor or pharmacist before use if you are. ousing non-nicotine stop smoking drugotaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.. ousing non-nicotine stop smoking drug. otaking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.. Stop use and ask doctor if. omouth problems occuropersistent indigestion or severe sore throat occursoirregular heartbeat or palpitations occuroyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeatoyou have symptoms of an allergic reaction (such as difficulty breathing or rash). omouth problems occur. opersistent indigestion or severe sore throat occurs. oirregular heartbeat or palpitations occur. oyou get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat. oyou have symptoms of an allergic reaction (such as difficulty breathing or rash). Keep out of reach of children and pets.. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222).