{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 27 } }, "results": [ { "effective_time": "20121031", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, DIPROPYLENE GLYCOL, ISOHEXADECANE, BUTYLENE GLYCOL, DIMETHICONE, PROPANEDIOL, BEHENYL ALCOHOL, SILICA, BEHENIC ACID, GLYCERYL STEARATE SE, PEG-60 GLYCERYL ISOSTEARATE, BENTONITE, PHENOXYETHANOL, PEG-5 GLYCERYL STEARATE, BATYL ALCOHOL, VP/EICOSENE COPOLYMER, SODIUM HYDROXIDE, TRISODIUM EDTA, CELLULOSE GUM, XANTHAN GUM, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, BOSWELLIA SERRATA GUM, SODIUM CARBONATE, BUTYROSPERMUM PARKII (SHEA) SEEDCAKE EXTRACT, PVP, BHT, CHLORPHENESIN, GENTIANA URNULA FLOWER EXTRACT, DISODIUM EDTA, TOCOPHEROL" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED. GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF RASH OR IRRITATION DEVELOPS AND PERSISTS, DISCONTINUE USE AND CONTACT A DOCTOR. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED. GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY." ], "when_using": [ "WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER." ], "spl_product_data_elements": [ "NARS PRO-PRIME MULTI-PROTECT PRIMER Ensulizole, Octinoxate, Octocrylene, and Oxybenzone Ensulizole Ensulizole Octinoxate Octinoxate Octocrylene Octocrylene Oxybenzone Oxybenzone WATER DIPROPYLENE GLYCOL ISOHEXADECANE BUTYLENE GLYCOL DIMETHICONE PROPANEDIOL DOCOSANOL SILICON DIOXIDE BEHENIC ACID GLYCERYL MONOSTEARATE BENTONITE PHENOXYETHANOL BATILOL SODIUM HYDROXIDE EDETATE TRISODIUM CARBOXYMETHYLCELLULOSE SODIUM XANTHAN GUM ORANGE INDIAN FRANKINCENSE SODIUM CARBONATE BUTYLATED HYDROXYTOLUENE CHLORPHENESIN GENTIANA URNULA FLOWER EDETATE DISODIUM .ALPHA.-TOCOPHEROL" ], "openfda": {}, "version": "2", "stop_use": [ "IF RASH OR IRRITATION DEVELOPS AND PERSISTS, DISCONTINUE USE AND CONTACT A DOCTOR." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 mL Carton NARS PRO-PRIME™ MULTI-PROTECT PRIMER SPF 30 SUNSCREEN PA+++ NET WT. 1 Oz. 30 mL Principal Display Panel - 30 mL Carton" ], "set_id": "09d112ae-2bbe-40b5-a3a5-70d560bfe20d", "id": "7e3f1103-15f1-47f1-917a-8292a25d0db5", "active_ingredient": [ "ACTIVE INGREDIENTS ENSULIZOLE 3%, OCTINOXATE 7.3%, OCTOCRYLENE 3%, OXYBENZONE 3%" ] }, { "effective_time": "20101123", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), glycerin, PEG-8, hydrated silica, silica, PEG/PPG-116/66 copolymer, calcium sulfate, sodium lauryl sulfate, flavor, dipotassium phosphate, sodium carbonate, sodium saccharin, cellulose gum, titanium dioxide" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "Age Defying Fluoride and Liquid Calcium Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE GLYCERIN POLYETHYLENE GLYCOL 400 HYDRATED SILICA SILICON DIOXIDE POLOXALENE CALCIUM SULFATE SODIUM LAURYL SULFATE PHOSPHATE ION SODIUM CARBONATE SACCHARIN SODIUM DIHYDRATE CARBOXYMETHYLCELLULOSE SODIUM TITANIUM DIOXIDE" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions supervise children as necessary until capable of using without supervision do not swallow adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste Protects and Rebuilds Enamel Mint AGE DEFYING NET WT. 4.3 OZ. (121g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "246bc89a-43f0-484e-8b31-4757b683ca17", "id": "27a40ee2-4f97-4190-8862-1be063e3a180", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20120307", "spl_unclassified_section_table": [ "
Weeks 1 through 6 Weeks 7 through 9 Weeks 10 through 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
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
" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 overdoe, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll-free 1-866-751-9303" ], "pregnancy_or_breast_feeding": [ "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." ], "storage_and_handling": [ "Other information each lozenge contains: sodium 15 mg Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge sugar alcohol content: 1 g mannitol per lozenge store at 20-25°C (68-77°F) keep vial closed and protect from light" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving associated with quitting smoking" ], "set_id": "26bfbdad-d67a-41b9-803d-967d438a2672", "id": "40855932-0f9c-4ee0-96a5-4512c6ba9d66", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg (nicotine)" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every1 to 2 hours 1 lozenge every2 to 4 hours 1 lozenge every4 to 8 hours
" ], "inactive_ingredient": [ "Inactive ingredients aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "warnings": [ "Warnings Enter section text here 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. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdoes such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat 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 overdoe, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "good sense nicotine Nicotine Polacrilex NICOTINE NICOTINE POLACRILIN ASPARTAME MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM L873" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdoes such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat" ], "spl_unclassified_section": [ "Consumer Information Nicotine Polacrilex Lozenge 2 mg and 4 mg User's Guide How to Use Nicotine Polacrilex Lozenges and Tips 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. PLANNING YOUR SUCCESS 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 9 Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on a regular schedule (as outlined in this User's Guide). 3) Stop smoking completely when you start using Nicotine Polacrilex Lozenges. Even a single cigarette is likely to put you right back to square one. 4) This User's Guide outlines a 12-week plan for Nicotine Polacrilex Lozenges. Even though you may feel confident about your non-smoking status after a few weeks, it's important to stick with the plan to help you remain smoke free. 5) Nicotine Polacrilex Lozenges work best when used together with a support plan. 6) After the first six weeks, start using fewer Nicotine Polacrilex Lozenges, as directed in the instructions, so you can become smoke-and nicotine-free by the end of the 12 week plan. 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. You've made the most important decision of all, to stop smoking. And by choosing Nicotine Polacrilex Lozenges to help you, you're starting on the right path. Now remember, using Nicotine Polacrilex Lozenges doesn't just mean taking a Nicotine Polacrilex Lozenge. It means setting and following a program like the one we suggest in this User's Guide. Your own success depends on your effort, your level of addiction to tobacco, and your commitment to following your program. LET'S FACE IT. Quitting smoking isn't easy! You or someone you know may have tried unsuccessfully. That's okay. It's 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 User's 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 a reason for quitting–whether you're 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. There's a wallet card inside the back cover of this User's Guide. Write your reasons on the card and carry it with you. When you have an urge to smoke or experience a difficult moment it can help you focus on your reasons for quitting. Lots of people quit with a co-worker, spouse or friend and use them as a 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 back cover of this User's Guide. UNDERSTANDING THE DOUBLE-EDGED SWORD. Smoking has two addictive components, a physical and a 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 you're ready, it's time to begin. But first, read and consider the following important warnings. 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. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products. 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 ulcers 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 problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat 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 a Poison Control Center right away. YOU’RE READY TO START. Okay, you're ready. To become a non-smoker, start today. Now before you do anything else, you have a bit of planning to do. Read this User's 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 4mg Nicotine Polacrilex Lozenges. If you smoke your first cigarette more than 30 minutes after waking up use the 2mg Nicotine Polacrilex Lozenges. Next, plan your quitting schedule. Get a calendar to follow your progress and mark the following four important dates (see the stickers in the middle of this booklet). THE PROGRAM STEP 1. (Weeks 1-6). Starting on your quit date it's best to use at least 9 Nicotine Polacrilex Lozenges each day, one every 1 - 2 hours. First choose the day you plan to quit (make it soon). Place the Step 1 sticker on this date. That's the day you will stop smoking cigarettes completely and 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 a Nicotine Polacrilex Lozenge every 1 to 2 hours and at least 9 lozenges each day for the first 6 weeks to help prevent unexpected cravings and improve your chances of quitting. These aren't 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 a 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 instructions on page 9 before you take your first Nicotine Polacrilex Lozenge. STEP 2. (The next three weeks, that is weeks 7-9). At the beginning of week 7 start using fewer Nicotine Polacrilex Lozenges, one every 2-4 hours. After six weeks, you should wait a little longer between lozenges, one lozenge every two to four hours. This will help you gradually use fewer Nicotine Polacrilex Lozenges. Put the Step 2 sticker on the first day of week 7 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 4 to 8 hours. Put the Step 3 sticker 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 stop using Nicotine Polacrilex Lozenges to become both cigarette and nicotine-free. Put the 'EX-SMOKER' sticker on your calendar on the date 12 weeks after the day you stopped smoking and started using Nicotine Polacrilex Lozenges. You should not use Nicotine Polacrilex Lozenges beyond this date. BE PREPARED. Since smoking is an addiction, it is hard to quit. Even after you stop, there will be times when you WANT a 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 don't give in. For example: think about situations when you usually get a 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 a walk. In other words, break the association between your usual habits and cigarettes. If you do encounter a situation where you feel a strong craving, fight it! Take a 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 quitting! To prepare for tough situations, assemble a “survival package” – items that can keep you distracted in case you get a craving. For example, you may include cinnamon gum or hard candy, relaxing music, and things to keep your hands busy like a smooth stone, paper clips, or a rubber ball. Track your progress as you quit. Keep a journal. Write down how many pieces of Nicotine Polacrilex Lozenges you use each day. Note if and when you get a craving. If you slip and have a cigarette, don't 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 a CD or video, which you can earn by overcoming difficult hurdles. HOW Nicotine Polacrilex LOZENGES WORK. Nicotine Polacrilex Lozenges are a 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 a lower, steady level of nicotine to your blood. When used as directed, Nicotine Polacrilex Lozenges help you regulate, control, and gradually reduce your body's craving for nicotine. The good news is that Nicotine Polacrilex Lozenges contain no tar or carbon monoxide, and therefore don't 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 aren't 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 a 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 you're using Nicotine Polacrilex Lozenges correctly. IMPORTANT: Don't worry or give up if you do not like the taste of the lozenge at first. Nicotine Polacrilex Lozenges are a medication, not a candy. Most people get used to the taste after a day or two. Remember, staying with the plan will help you quit. Stop smoking completely before you start using Nicotine Polacrilex Lozenges. 1) Remove the Nicotine Polacrilex Lozenge from the QuitTube®. 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 a 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 1 through 6 Weeks 7 through 9 Weeks 10 through 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. Stop using the lozenge at the end of 12 weeks (3 months). FOR THE BEST CHANCE OF QUITTING, use Nicotine Polacrilex Lozenges on a regular schedule, using at least 9 lozenges a day during the first 6 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. Stop using Nicotine Polacrilex Lozenge at the end of week 12. If you still feel the need to use Nicotine Polacrilex Lozenge after week 12, talk with your doctor. 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: Look to your family and friends for support. Let them know what to do or avoid doing to help you quit. Throw away ALL cigarettes, ashtrays, matches, lighters. You don't need them. You don't want them and you want to make it difficult to go back. Keep yourself occupied. Take a walk. See a movie. See friends. Do anything to keep your mind off cigarettes. Calculate all the money you'll save by not buying cigarettes. Probably well over $1,000 a year! $1,000 a year? Think of what you can spend it on! Know what situations are going to make you want to smoke. Plan now how you'll avoid them or deal with them so you don't smoke. Keep Nicotine Polacrilex Lozenges next to your bed so you're prepared when you get up. A lot of people get cravings first thing in the morning. Make an appointment to see your dentist and get the tobacco stains cleaned off. While you're 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. Now that your house is smoke-free, try to spend most of your time in smoke-free environments. If you usually smoked with coffee or alcohol, try to keep away from them for now. Remember you are also trying to break a habit. Smoking is a “hands-on” habit. So use something else to occupy your hands: a rubber band or a pen. Now's a good time to get active. Find activities to take your mind off cigarettes and relax. Take up jogging, swimming, or walking. Don't 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. Laugh. Watch a sitcom. Read a comic book. It really helps. REMEMBER: Urges to smoke are temporary. They'll pass, even if you don't smoke. WHAT YOU CAN EXPECT. As you are successful at staying smoke-free, initially you will probably notice a few of the following typical withdrawal symptoms, so don't 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 a 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 a little out of sorts, get headaches, feel light-headed, or have trouble sleeping. Your smoker’s cough may get worse before it improves. But fear not, it’s a positive sign. Coughing helps clean your lungs of the tar residue you got from smoking. After A Couple Of Weeks. Your confidence and ability to cope with urges to smoke should be getting stronger. But don't be over-confident and think you can smoke just one cigarette. Even now, having even a single puff can lead to a 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. You've also probably noticed your withdrawal symptoms are subsiding (though don't worry if they're 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 can't 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 Smoke? “What if I relapse?” One cigarette is a slip-up, but it's not the end of the quit effort. Everybody slips at something. The key is this: forgive yourself and stop at that one cigarette. Don't 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 don't throw out your Nicotine Polacrilex Lozenges. Keep them for the next time you're 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. That’s important, because now you can plan better to deal with these moments next time. It’s true you stumbled, but don’t think of yourself as having failed. Encourage yourself by treating the last attempt as a learning experience, even a “trial run” for the real thing. Take a 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 you’ll be best equipped to deal with the unexpected cravings. Don’t forget; quitting isn't easy and it takes practice to do anything. Stopping smoking is no different. YOU’VE MADE IT. Once your twelve week quitting program is over, you’ve taken your last Nicotine Polacrilex Lozenge. Now you are both cigarette and nicotine-free. Get up and give yourself a standing ovation. We mean it. Do you realize that you have just done a really difficult thing? Now’s a good time to think back on the process. Think of all your reasons for quitting smoking. Think of your goals. Think of how they’re going to be a reality now. Think of what you’re 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 a proud non-smoker. FREQUENTLY ASKED QUESTIONS. 1. When I stop smoking and start using Nicotine Polacrilex Lozenges how will I feel? Nicotine 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: unexpected craving or urges for cigarettes anxiety, irritability, restlessness, mood changes, nervousness drowsiness trouble concentrating increased appetite and weight gain headaches, muscular pain, constipation, fatigue Nicotine 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 another? Nicotine 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. Remember, don't use Nicotine Polacrilex Lozenges together with nicotine patches or other nicotine containing products. 3. Can Nicotine Polacrilex Lozenges do any harm? Some 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 pages 3 and 4. 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 I put on weight? In the first couple of months after quitting smoking, some people do put on a few pounds. But think of it this way. Overall, you’ll 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 smoking? If you normally smoke a pack and a half a day, your total cost of using Nicotine Polacrilex Lozenges during the 12-week period should be less than smoking. But guess what? After you’ve finished the Nicotine Polacrilex Lozenge program all that money you used to spend on cigarettes is now savings. And think of the health issues you’ll hopefully be able to avoid. 6. What if I have a cigarette and start smoking? Don't panic. First, don't 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 a cigarette will make everything better. It won’t. Find other ways to relax and unwind. The blues. You may be especially vulnerable when you feel bored or blue. Remember that having a 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 a cigarette. Watch out for these situations: they can trigger a relapse. You probably know which one(s) are most dangerous for you; plan ahead to deal with the situation effectively. Always remember that you’re trying to break a 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. Escape. Leave the situation, even for a few minutes. Most temptations don’t last long. Distract yourself. Get your mind off smoking. Think of something else or get busy with something. Relax. Don't let stress get to you. Think of pleasant relaxing things; breathe slowly and regularly. Let the stress drain out of you. Talk yourself out of it. What you say to yourself matters. So, remind yourself how important it is for you to quit; remind yourself you can't have just one; or just command yourself to STOP. PACKAGED BY Perrigo® ALLEGAN, MI 49010 U.S.A. www.perrigo.com WALLET CARD My most important reasons to quit smoking are: WHERE TO CALL FOR HELP: American Lung Association 1-800-586-4872 American Cancer Society 1-800-227-2345 American Heart Association 1-800-242-8721 Quitting Buddy or Friend who has Quit 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 on the next page to receive your valuable personalized Smoke Free Habits plan and many other stop smoking tools and resources. Your Personal Enrollment Code XXXXXX-X How To Enroll Stopping 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: Go online to www.SmokeFreeHabits.com Enter your Personal Enrollment Code and 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 1-866-751-9303, 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 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 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. Place these stickers on your calendar: At the Beginning of Week #1 (Quit Date) At the Beginning of Week #7 Place these stickers on your calendar: At the Beginning of Week #10 12 Weeks After Quit Date Smoke Free Habits.com image Step 1 image Step 2 image Step 3 image 12 Weeks After Quit Date image" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68258-7992-07 NDC 68258-7992-07" ] }, { "effective_time": "20120525", "inactive_ingredient": [ "inactive ingredient: niacinamide, water,copper tripeptide, zinc pyrithion, chamaecyparis, obtusa water, sodium chloride, sodium metasilicate, sodium thiosulfate, sodium carbonate, sodium citrate, citric acid, tetrasodium EDTA" ], "purpose": [ "hair growth, hair loss prevention and scalp protectant" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "- keep out of eyes, ears and mouth - if contact occurs, rinse away with plenty of cold water" ], "spl_product_data_elements": [ "HairQ-Plus BIOTIN BIOTIN BIOTIN WATER SODIUM CHLORIDE SODIUM THIOSULFATE SODIUM CARBONATE SODIUM CITRATE CITRIC ACID MONOHYDRATE EDETATE SODIUM NIACINAMIDE PYRITHIONE ZINC" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "- for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "- apply only for scalp - apply 2 or 3 times a day with 5~6ml - massage with your finger over 2 min and let them dry" ], "set_id": "28cfb31b-bd12-4081-be81-ca29cdca9f2b", "id": "1c58c007-5cfa-45e4-921d-78c68ceecb28", "active_ingredient": [ "active ingredient: biotin" ] }, { "effective_time": "20120523", "inactive_ingredient": [ "inactive ingredient: water,copper tripeptide, sodium chloride, sodium metasilicate, sodium thiosulfate, sodium carbonate, sodium citrate, citric acid, tetrasodium EDTA" ], "purpose": [ "hair growth, hair loss prevention and scalp protectant" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "- keep out of eyes, ears and mouth - if contact occurs, rinse away with plenty of cold water" ], "spl_product_data_elements": [ "HairQ PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM CHLORIDE SODIUM THIOSULFATE SODIUM CARBONATE SODIUM CITRATE CITRIC ACID MONOHYDRATE EDETATE SODIUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "- for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "- apply only for scalp - apply 2 or 3 times a day with 5~6ml - massage with your finger over 2 min and let them dry" ], "set_id": "2bc50f1d-e6dd-4229-87aa-58a9b5a91490", "id": "061ba527-b2fb-472d-b5b3-1b7d598b1aff", "active_ingredient": [ "active ingredient: zinc pyrithion" ] }, { "effective_time": "20101130", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG/PPG-38/8 copolymer, PEG/PPG-116/66 copolymer, sodium carbonate peroxide, silica, water, sodium saccharin, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Do not use if irritation occur s and persists. _________________________________________________ Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Peroxi Care Baking Soda and Peroxide Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOLS SODIUM CARBONATE SILICON DIOXIDE WATER SACCHARIN SODIUM DIHYDRATE SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue thoroughly after brushing adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste PEROXI CARE Baking Soda and Peroxide FRESH MINT KILLS GERMS FOR FRESH BREATH NET WT. 6.0 OZ. (170g) FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "3517b24b-e4b2-4cc4-9ddc-ee7e4e92c658", "id": "10ba9300-3564-4117-872a-6cca0138377b", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20101130", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG-8, PEG/PPG-116/66 copolymer, tetrasodium pyrophosphate, sodium carbonate peroxide, silica, sodium saccharin, flavor, water, sodium lauryl sulfate, sodium lauroyl sarcosinate." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Do not use if irritation occur s and persists. _________________________________________________ Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Peroxie Care Tartar Control Baking Soda and Peroxide Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOLS SODIUM PYROPHOSPHATE SODIUM CARBONATE SILICON DIOXIDE SACCHARIN SODIUM DIHYDRATE WATER SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue thoroughly after brushing adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste Tartar Control PEROXI CARE Baking Soda and Peroxide FRESH MINT KILLS GERMS FOR FRESH BREATH NET WT. 6.0 OZ. (170g) FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "358f7c5b-b2bb-4446-971e-5ae7548c38dc", "id": "1c3b010f-3061-4a96-8579-cfd3016536b0", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20120307", "inactive_ingredient": [ "Inactive ingredients aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 overdoe, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Enter section text here 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. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat 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 overdoe, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? call toll-free 1-866-751-9303" ], "spl_product_data_elements": [ "Good Sense Nicotine Nicotine Polacrilex NICOTINE NICOTINE ASPARTAME MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM L344" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "pregnancy_or_breast_feeding": [ "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." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat" ], "storage_and_handling": [ "Other information each lozenge contains: sodium 15 mg Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge sugar alcohol content: 1 g mannitol per lozenge store at 20-25°C (68-77°F) keep vial closed and protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68258-7991-07 NDC 68258-7991-07" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving associated with quitting smoking" ], "set_id": "4bb7687d-3ee0-47a3-aa43-146dede4cf55", "id": "4b7832cb-8420-47b0-b947-363aa54e2ca1", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 2 mg (nicotine)" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every1 to 2 hours 1 lozenge every2 to 4 hours 1 lozenge every4 to 8 hours
" ] }, { "effective_time": "20140728", "inactive_ingredient": [ "Inactive Ingredients corn starch, D&C yellow #10, gum base, noncrystallizing sorbitol solution, peppermint oil, sodium bicarbonate, sodium carbonate, sorbitol" ], "purpose": [ "Purpose Stop Smoking Aid" ], "keep_out_of_reach_of_children": [ "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." ], "warnings": [ "Warnings If you are pregnant or breastfeeding, only use this medicine on the advice of your healthcare 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. Do not use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products. 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 heart beat or palpitations occur. • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat. 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." ], "questions": [ "Questions or comments? call TEVA Pharmaceuticals USA Medical Affairs Department at 1-888-838-2872 weekdays (8:30 a.m. to 5:00 p.m. EST)." ], "spl_product_data_elements": [ "Nicotine Polacrilex NICOTINE NICOTINE NICOTINE STARCH, CORN PEPPERMINT OIL SODIUM BICARBONATE SORBITOL SODIUM CARBONATE D&C YELLOW NO. 10" ], "ask_doctor": [ "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." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "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 • stop smoking completely when you begin using the gum • if you smoke less than 25 cigarettes a day; use 2 mg nicotine gum • if you smoke 25 or more cigarettes a day; use 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. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if • mouth, teeth or jaw problems occur. • irregular heart beat or palpitations occur. • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat." ], "storage_and_handling": [ "Other Information • each piece contains: calcium 61 mg, sodium 8.44 mg • Store at 20° to 25°C (68° to 77°F) • Protect from light" ], "do_not_use": [ "Do not use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 4 mg Carton NDC 0172- 6731 -27 Compare to the active ingredient in Nicorette ® NICOTINE POLACRILEX GUM USP 4 mg (nicotine) Original Stop Smoking Aid Starter Kit: Includes stop smoking plan with User's Guide For those who smoke 25 or more cigarettes a day If you smoke less than 25 cigarettes a day: use nicotine polacrilex gum USP 2 mg Free Audio CD upon request. See inside. 108 Pieces, 4 mg Each TEVA PRINCIPAL DISPLAY PANEL - 4 mg Carton" ], "indications_and_usage": [ "Use • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." ], "set_id": "4e01f028-f7d2-4dbd-a56e-e6e2ba67eabc", "id": "c575d382-3ba0-4665-b5fb-4a7e1e3669b1", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active Ingredient (in each chewing piece) Nicotine polacrilex USP (equal to 4 mg nicotine)" ], "dosage_and_administration_table": [ "
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
" ] }, { "effective_time": "20101112", "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients Water, calcium carbonate, sodium hypochlorite, sodium carbonate, sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, sorbic acid, stearic acid, diproplyene glycol, dimethyl sulfoxide, color." ], "keep_out_of_reach_of_children": [ "CHILDREN n Keep away from children. n Do not use in the eyes or apply over large areas of the body. n Do not use if allergic to any ingredient listed on this label." ], "purpose": [ "PURPOSE Active Ingredients Purpose Zinc acetate (.1% by volume) Skin Protectant" ], "warnings": [ "WARNINGS Warnings n For external use only; do not swallow. n Keep away from children. n Do not use in the eyes or apply over large areas of the body. n Do not use if allergic to any ingredient listed on this label." ], "when_using": [ "WHEN USING Directions Step 1: Wet the skin with water and apply powder to the affected area. Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins. Step 3: Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops . Step 4: Seek immediate medical attention. Store at 40 to 120 degrees F." ], "spl_product_data_elements": [ "Advanced Jellyfish Sting Kit zinc acetate zinc acetate zinc dimethyl sulfoxide ascorbic acid dipropylene glycol water sorbic acid magnesium stearate stearic acid sodium dodecylbenzenesulfonate calcium carbonate sodium carbonate sodium hypochlorite" ], "ask_doctor": [ "ASK DOCTOR Directions Step 1: Wet the skin with water and apply powder to the affected area. Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins. Step 3: Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops. Step 4: Seek immediate medical attention." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Directions Step 1: Wet the skin with water and apply powder to the affected area. Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins. Step 3: Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops. Step 4: Seek immediate medical attention." ], "stop_use": [ "" ], "do_not_use": [ "DO NOT USE Warnings n For external use only; do not swallow. n Keep away from children. n Do not use in the eyes or apply over large areas of the body. n Do not use if allergic to any ingredient listed on this label." ], "package_label_principal_display_panel": [ "Image of product Image of product image of product" ], "indications_and_usage": [ "USE Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces. Contains surfactants to break down oily toxins." ], "set_id": "57a5d86e-5fa5-4bc6-9fe9-ec7d617fadfb", "id": "94aab24d-fca0-490a-9eac-822490ac8a54", "active_ingredient": [ "DRUG FACTS Uses Temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces. Contains surfactants to break down oily toxins. ____________________________________________________________________ Warnings n For external use only; do not swallow. n Keep away from children. n Do not use in the eyes or apply over large areas of the body. n Do not use if allergic to any ingredient listed on this label. ____________________________________________________________________ Directions Step 1: Wet the skin with water and apply powder to the affected area. Step 2: Use water to wet the special cloth and use it to scrub the affected area to remove jellyfish barbs and to mix the protectant with any remaining toxins. Step 3: Repeat Steps 1 and 2 a minimum of three times or until stinging and pain stops. Step 4: Seek immediate medical attention. ____________________________________________________________________ Other information Store at 40 to 120 degrees F. Net contents of kit: One special scrub cloth and one powder vial. Net contents of powder vial: 3 mL. This product contains no alcohol; no animal products; no biological products. ____________________________________________________________________ Inactive ingredients Water, calcium carbonate, sodium hypochlorite, sodium carbonate, sodium dodecylbenzene sulfonate, ascorbic acid, magnesium stearate, sorbic acid, stearic acid, diproplyene glycol, dimethyl sulfoxide, color. ____________________________________________________________________ Questions and Side effects Report any side effects to Phillips Company, 311 Chickasaw St, Millerton, OK USA 74750 Email: phillips@123phillips.com", "ACTIVE INGREDIENTS Active Ingredients Purpose Zinc acetate (.1% by volume) Skin Protectant" ] }, { "effective_time": "20101203", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG/PPG-38/8 copolymer, PEG/PPG-116/66 copolymer, calcium sulfate, silica, sodium lauryl sulfate, flavor, PEG-8, dipotassium phosphate, sodium saccharin,sodium carbonate peroxide." ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warning Do not use if irritation occur s and persists. _________________________________________________ Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Complete Care Enamel Strengthening Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOLS POLOXALENE CALCIUM SULFATE SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 400 PHOSPHATE ION SACCHARIN SODIUM DIHYDRATE SODIUM CARBONATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue thoroughly after brushing adults and children 2 years and older brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years consult a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste PROTECTS and REBUILDS ENAMEL COMPLETE CARE Enamel Strengthening FRESH MINT NET WT. 6.0 OZ. (170g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "5ebaf670-ebb7-418a-b163-c9f1627864cf", "id": "71fb849f-f7f8-470e-9fd7-db1366056bae", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20150905", "inactive_ingredient": [ "Propylene Glycol, Cysteamine HCl, Ethanolamine Thioglycolate, Ethanolamine, Hydrolyzed Collagen, Cetrimonium Chloride, Glycine, Sodium Carbonate, Algin, Cellulose Gum, Glutamine, Disodium EDTA, Glycerin, Alcohol, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Water" ], "purpose": [ "Hair Perm" ], "keep_out_of_reach_of_children": [ "Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away." ], "warnings": [ "For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop using and ask a doctor if rash occurs." ], "spl_product_data_elements": [ "ELF Perm PANTHENOL PANTHENOL PANTHENOL PROPYLENE GLYCOL CYSTEAMINE HYDROCHLORIDE MONOETHANOLAMINE THIOGLYCOLATE MONOETHANOLAMINE CETRIMONIUM CHLORIDE GLYCINE SODIUM CARBONATE SODIUM ALGINATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLUTAMINE EDETATE DISODIUM GLYCERIN ALCOHOL SCUTELLARIA BAICALENSIS ROOT GREEN TEA LEAF GLYCYRRHIZA GLABRA WATER" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Shampoo and remove excessive moisture from hair with a towel Apply the first solution and roll hair in curlers Allow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed) Apply second solution and rinse" ], "package_label_principal_display_panel": [ "image description" ], "indications_and_usage": [ "Shampoo and remove excessive moisture from hair with a towel Apply the first solution and roll hair in curlers Allow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed) Apply second solution and rinse" ], "set_id": "6645ae29-0c6d-4632-b972-482df7df098c", "id": "3dc369ae-605a-4e67-9757-09bcb97fc6c5", "active_ingredient": [ "Panthenol 0.1%" ] }, { "effective_time": "20101129", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG/PPG-116/66 copolymer, sodium carbonate peroxide, silica, water, sodium saccharin, flavor zinc citrate trihydrate, sodium lauryl sulfate, sodium lauroyl sarcosinate" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if irritation occurs and persists." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Complete Care Tartar Control Extra Whitening with Baking Soda and Peroxide Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOL 400 POLOXALENE SODIUM PERCARBONATE SILICON DIOXIDE WATER SACCHARIN SODIUM DIHYDRATE ZINC CITRATE SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue throughly after brushing adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste Tartar Control Fresh Mint COMPLETE CARE Extra Whitening with Baking Soda and Peroxide NET WT. 6.0 OZ. (170g) CLEANS. WHITENS. FRESHENS. FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "700c72cf-53e9-45c4-a065-cbe95c00dc52", "id": "17c214a7-d69f-494e-8af0-1c352662ec23", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20140924", "inactive_ingredient": [ "Inactive Ingredients Acesulfame potassium, calcium carbonate, carnauba wax, flavors, gelatin, glycerin, gum base, maltitol, saccharin, saccharin sodium, sodium bicarbonate, sodium carbonate, sorbitol, talc, titanium dioxide" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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." ], "warnings": [ "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 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 or nicotine overdose, such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat 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." ], "questions": [ "Questions or Comments ? Support Counseling: 1-866-902-3010 Mon. – Fri. 9AM – 8PM EST Product Questions or Comments: 1-800-452-0051" ], "spl_product_data_elements": [ "Thrive Nicotine Polacrilex Gum NICOTINE NICOTINE ACESULFAME POTASSIUM CALCIUM CARBONATE CARNAUBA WAX GELATIN GLYCERIN MALTITOL SACCHARIN SACCHARIN SODIUM SODIUM BICARBONATE SODIUM CARBONATE SORBITOL TALC TITANIUM DIOXIDE Light Blue" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "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 ● stop smoking completely when you begin using the gum ● if you smoke less than 25 cigarettes a day; use according to the following 12 week schedule: ● 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 changes 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. ● It is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor. 12 Week Schedule" ], "pregnancy_or_breast_feeding": [ "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." ], "stop_use": [ "Stop use and ask a doctor if ● mouth, teeth or jaw problems occur ● irregular heartbeat or palpitations occur ● you get symptoms or nicotine overdose, such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat 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." ], "spl_unclassified_section": [ "Other Information ● Each piece contains: calcium 91mg, sodium 11mg ● Store at 20-25°C (68-77°F)● protect from light", "Generic Section Cover Page Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Thrive 2mg Carton" ], "indications_and_usage": [ "Uses ● reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "725b3d3f-e091-4a61-b9f6-c51171ef59c5", "id": "725b3d3f-e091-4a61-b9f6-c51171ef59c5", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg of nicotine)" ] }, { "effective_time": "20101129", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG-8, PEG/PPG-116/66 copolymer, sodium carbonate peroxide, tetrasodium pyrophosphate, silica, sodium saccharin, flavor, water, sodium lauryl sulfate, sodium lauroyl sarcosinate" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if irritation occurs and persists." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET or visit www.myoralcare.com" ], "spl_product_data_elements": [ "Advance White Baking Soda and Peroxide Tartar Control Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOL 400 POLOXALENE SODIUM CARBONATE SODIUM PYROPHOSPHATE SILICON DIOXIDE SACCHARIN SODIUM DIHYDRATE WATER SODIUM LAURYL SULFATE SODIUM LAUROYL SARCOSINATE Fresh Mint" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision rinse away toothpaste residue throughly after brushing adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel Bonus 20% More than 6 oz. ARM AND HAMMER The Standard of Purity Fluoride Anti-Cavity Toothpaste Clinically Proven to Whiten Teeth! Fresh Mint ADVANCE WHITE Baking Soda and Peroxide Tartar Control NET WT. 6.0 OZ. (170g) FRESH FROM THE DENTIST FEELING OF CLEAN Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "73e7f7c9-ef98-42cd-b670-68d7e9cb025f", "id": "176428a4-ea6b-4b8c-82c9-c05163638772", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20140506", "spl_unclassified_section_table": [ "
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.
", "
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
", "
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
" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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)." ], "questions": [ "Questions or comments? call 1-866-677-7858" ], "pregnancy_or_breast_feeding": [ "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." ], "storage_and_handling": [ "Other information each piece contains: calcium 100 mg and sodium 11 mg • store at 20-25°C (68-77°F) • protect from light •" ], "indications_and_usage": [ "Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking •" ], "set_id": "78e41a43-35ea-4c38-a8c3-0dcfc34c6a8e", "id": "c8f056bb-0ec7-49bb-96c5-723dd5d93a41", "ask_doctor_or_pharmacist": [ "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. •" ], "active_ingredient": [ "Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine)" ], "dosage_and_administration_table": [ "
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
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, calcium carbonate, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc" ], "warnings": [ "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. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products • 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 • 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)." ], "spl_product_data_elements": [ "Sunmark Nicotine Nicotine Polacrilex NICOTINE NICOTINE ACESULFAME POTASSIUM CALCIUM CARBONATE CARNAUBA WAX SODIUM BICARBONATE SODIUM CARBONATE SORBITOL TALC POLACRILIN off white" ], "ask_doctor": [ "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 •" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "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 • stop smoking completely when you begin using the gum • 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. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor. •" ], "stop_use": [ "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) •" ], "spl_unclassified_section": [ "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. You must really want to quit smoking for Nicotine Polacrilex Gum to help you. 1. You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Nicotine Polacrilex Gum. See page 10. (For Booklet Only) 2. You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Nicotine Polacrilex Gum. See chart on back side of leaflet. (For Leaflet Only) You should continue to use Nicotine Polacrilex Gum as explained in this User’s Guide for 12 full weeks. 3. Nicotine Polacrilex Gum works best when used together with a support program - See page 3 for details. (For Booklet Only) 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. (For Leaflet Only) If you have trouble using Nicotine Polacrilex Gum, ask your doctor, pharmacist or health care professional. 5. To request a free audio CD containing tips to help make quitting easier, call 1-866-677-7858 (ONE CD PER CUSTOMER). 6. 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 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 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 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 back cover of this User’s Guide. (For Booklet Only) You are more likely to stop smoking by using Nicotine Polacrilex 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. (For Leaflet Only) 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 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 inside the back cover 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. (For Booklet Only) 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. (For Leaflet Only) 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 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 important warnings you should consider. Some Important Warnings. This product is only for those who want to stop smoking. 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. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products. • 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) • 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). Keep out of reach of children and pets. Let's Get Started. Becoming a nonsmoker starts today. First, check that you bought the right starting dose. use Nicotine Polacrilex Gum, 4 mg. 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 stickers in the center of this User’s Guide: (For Booklet Only) If you smoke your first cigarette within 30 minutes of waking up, If you smoke your first cigarette more than 30 minutes after waking up, Becoming a nonsmoker starts today. First, check that you bought the right starting dose. use Nicotine Polacrilex Gum, 4 mg. 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: (For Leaflet Only) If you smoke your first cigarette within 30 minutes of waking up, If you smoke your first cigarette more than 30 minutes after waking up, 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 quit smoking cigarettes entirely and 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 follow the directions starting on pages 9 and 10. Place the Step 1 sticker on this date. (For Booklet Only) 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 quit smoking cigarettes entirely and 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. (For Leaflet Only) 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 sticker on this date (the first day of week seven). (For Booklet Only) 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). (For Leaflet Only) STEP 3. (Weeks 10-12). The day you’ll further reduce your 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 sticker 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. (For Booklet Only) STEP 3. (Weeks 10-12). The day you’ll further reduce your 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. (For Leaflet Only) End of treatment: The day you’ll complete Nicotine Polacrilex Gum therapy. Nicotine Polacrilex Gum should not be used for longer than twelve weeks. Identify the date thirteen weeks after the date you chose in Step 1, and place the \"EX-SMOKER\" sticker on your calendar. (For Booklet Only) End of treatment: The day you’ll complete Nicotine Polacrilex Gum therapy. Nicotine Polacrilex Gum should not be used for longer than twelve weeks. Identify the date thirteen weeks after the date you chose in Step 1, and place the \"EX-SMOKER\" reminder on your calendar. (For Leaflet Only) 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 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 headache, nausea, upset stomach, and dizziness. How To Use Nicotine Polacrilex Gum. Before you can use Nicotine Polacrilex Gum correctly, you have to practice! That sounds silly, but it isn’t. 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. If you are under 18 years of age, ask a doctor before use. Nicotine Polacrilex Gum isn’t like ordinary chewing gum. Stop smoking completely before you start using Nicotine Polacrilex Gum. 1. To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum according to the dosage schedule on page 10. (For Booklet Only) 2. To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum according to the dosage schedule on the back of this leaflet. (For Leaflet Only) Chew each Nicotine Polacrilex Gum piece . 3. very slowly several times 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.) 4. “PARK” the Nicotine Polacrilex Gum piece between your cheek and gum, and leave it there. 5. 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. 6. Park the Nicotine Polacrilex Gum piece again (in a different place in your mouth). 7. 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 or tingle won't return.) 8. Wrap the used Nicotine Polacrilex Gum piece in paper and throw away in the trash. 9. 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 nicotine 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. • STOP USING NICOTINE POLACRILEX GUM AT THE END OF WEEK 12. The following tips may help you with stopping Nicotine Polacrilex Gum at the end of 12 weeks. Set a stop date. • Use the same number of pieces of confectionery 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 if you: still feel the need to use Nicotine Polacrilex Gum at the end of week 12 • 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 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 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 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. • 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. 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 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 • 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. Remember, don’t use Nicotine Polacrilex Gum together with nicotine patches or other nicotine containing products. 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 advice from their doctor (see pages 4 and 5). (For Booklet Only) 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 advice from their doctor. Check the Some Important Warnings section on the front of this leaflet. (For Leaflet Only) 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 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. Good Luck! Recommended dosage schedule for Nicotine Polacrilex 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 Perrigo® Allegan, MI 49010 WALLET CARD (Side 1) WALLET CARD (Side 2) :02900 00 J4 (Booklet) :02952 00 J1 (Leaflet) 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 on the next page to receive your valuable personalized Smoke Free Habits plan and many other stop smoking tools and resources. (For Booklet Only) 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. (For Leaflet Only) 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 Follow your personalized Smoke Free Habits support plan. 1. Be sure to use Nicotine Polacrilex Gum as directed. 2. Throw away all of your cigarettes, lighters, and ashtrays. 3. 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. 4. Carry things to put in your mouth, like gum, hard candy or toothpicks. 5. Be active. Take a walk with a friend, ride your bike, walk the dog, play tennis. 6. 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. 7. Ask friends or family for support whenever you need it. 8. Place these stickers on your calendar: For booklet only Place these stickers on your calendar: For booklet only Place these reminders on your calendar: For leaflet only So You Decided To Quit.jpg What To Expect.jpg What To Expect.jpg Good Luck!.jpg Wallet Card 1.jpg Wallet Card 2.jpg Image 5 example upc.jpg Booklet Stickers 1.jpg Booklet Stickers 2.jpg Leaflet Stickers.jpg" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products •" ], "package_label_principal_display_panel": [ "Label Image" ] }, { "effective_time": "20140423", "inactive_ingredient": [ "Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate" ], "purpose": [ "Purposes Pain reliever/fever reducer" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present fever lasts more than 3 days new symptoms occur ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? 1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com" ], "spl_product_data_elements": [ "Aspirin Aspirin Aspirin Aspirin Carnauba Wax Silicon Dioxide Hypromelloses Sodium carbonate Zinc stearate BA;325" ], "ask_doctor": [ "Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have a sodium-restricted diet" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years: consult a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present fever lasts more than 3 days new symptoms occur ringing in the ears or a loss of hearing occurs" ], "storage_and_handling": [ "Other information each tablet contains: sodium 47 mg store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use. save carton for full directions and warnings" ], "do_not_use": [ "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 325 mg Tablet SEE NEW WARNINGS INFORMATION NEW! ASPIRIN ( NSAID ) PAIN RELIEVER/FEVER REDUCER REGULAR STRENGTH 325 mg FAST, SAFE PAIN RELIEF PRINCIPAL DISPLAY PANEL - 325 mg Tablet carton" ], "indications_and_usage": [ "Uses temporarily relieves headache menstrual pain minor pain of arthritis muscle pain pain and fever of colds toothache" ], "set_id": "84ce59f0-5cb4-4ba4-81f3-020676deb31e", "id": "95947bb4-46bb-435d-bb1c-d646aa556fdb", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis" ], "active_ingredient": [ "Active ingredient (in each tablet) Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug" ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, benzyl alcohol, butylhydroxy toluene, calcium polycarbophil, coconut and/or palm kernel oil, eugenol, flavors, magnesium stearate, maltodextrin, mannitol, modified corn starch, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 a Poison Control Center right away." ], "warnings": [ "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." ], "questions": [ "Questions or comments? call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am – 4:30 pm ET) Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108, Made in the U.K. ©2008 GlaxoSmithKline" ], "spl_product_data_elements": [ "COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ACESULFAME POTASSIUM BENZYL ALCOHOL BUTYLATED HYDROXYTOLUENE CALCIUM POLYCARBOPHIL COCONUT OIL PALM KERNEL OIL EUGENOL MAGNESIUM STEARATE MALTODEXTRIN MANNITOL MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM white to off-white NL2C COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ACESULFAME POTASSIUM BENZYL ALCOHOL BUTYLATED HYDROXYTOLUENE CALCIUM POLYCARBOPHIL COCONUT OIL PALM KERNEL OIL EUGENOL MAGNESIUM STEARATE MALTODEXTRIN MANNITOL MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM white to off-white NL4C" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions 4mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.", "Directions 2mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up , use 4mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up , use 2mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat" ], "spl_unclassified_section": [ "Other information Each lozenge contains: sodium, 18 mg store at 20 – 25 o C (68 – 77 o F) keep POPPAC tightly closed and protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing product" ], "package_label_principal_display_panel": [ "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 4mg STOP SMOKING AID 108 LOZENGES (4 Poppac TM Containers of 27) 4mg EACH FROM THE MARKETERS OF NICORETTE ® CHERRY FLAVOR Includes User’s Guide 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 Commit ® 2mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit Cherry 4 mg 108 lozenges carton", "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 2mg STOP SMOKING AID 108 LOZENGES (4 Poppac TM Containers of 27) 2mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide CHERRY FLAVOR 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 Commit ® 4mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit Cherry 2 mg 108 lozenges carton" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "86ceb63e-b433-4007-9a0f-6bbc823fa2fe", "id": "acc5cdf1-f816-43b2-938f-d645b03c11ab", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg Nicotine polacrilex, 2 mg" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
" ] }, { "effective_time": "20140924", "inactive_ingredient": [ "Inactive Ingredients Acesulfame potassium, calcium carbonate, carnauba wax, flavors, gelatin, glycerin, gum base, maltitol, saccharin, saccharin sodium, sodium bicarbonate, sodium carbonate, sorbitol, talc, titanium dioxide" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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." ], "warnings": [ "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 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 or nicotine overdose, such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat 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." ], "questions": [ "Questions or Comments ? Support Counseling: 1-866-902-3010 Mon. – Fri. 9AM – 8PM EST Product Questions or Comments: 1-800-452-0051" ], "spl_product_data_elements": [ "Thrive Nicotine Polacrilex Gum NICOTINE NICOTINE ACESULFAME POTASSIUM CALCIUM CARBONATE CARNAUBA WAX GELATIN GLYCERIN MALTITOL SACCHARIN SACCHARIN SODIUM SODIUM BICARBONATE SODIUM CARBONATE SORBITOL TALC TITANIUM DIOXIDE Light Blue" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "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 ● stop smoking completely when you begin using the gum ● if you smoke less than 25 cigarettes a day; use according to the following 12 week schedule: ● 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 changes 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. ● It is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor. 12 Week Schedule" ], "pregnancy_or_breast_feeding": [ "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." ], "stop_use": [ "Stop use and ask a doctor if ● mouth, teeth or jaw problems occur ● irregular heartbeat or palpitations occur ● you get symptoms or nicotine overdose, such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat 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." ], "spl_unclassified_section": [ "Other Information ● Each piece contains: calcium 91mg, sodium 11mg ● Store at 20-25°C (68-77°F)● protect from light", "Generic Section Cover Page Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Thrive 4mg Carton" ], "indications_and_usage": [ "Uses ● reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "99011d0e-9663-4a30-b3ef-c6288e3ef756", "id": "99011d0e-9663-4a30-b3ef-c6288e3ef756", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 4 mg of nicotine)" ] }, { "effective_time": "20120523", "inactive_ingredient": [ "inactive ingredient: niacinamide, water,copper tripeptide, zinc pyrithion, chamaecyparis, obtusa water, sodium chloride, sodium metasilicate, sodium thiosulfate, sodium carbonate, sodium citrate, citric acid, tetrasodium EDTA" ], "purpose": [ "hair growth, hair loss prevention and scalp protectant" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "- keep out of eyes, ears and mouth - if contact occurs, rinse away with plenty of cold water" ], "spl_product_data_elements": [ "HairQ-Plus BIOTIN BIOTIN BIOTIN WATER SODIUM CHLORIDE SODIUM THIOSULFATE SODIUM CARBONATE SODIUM CITRATE CITRIC ACID MONOHYDRATE EDETATE SODIUM NIACINAMIDE PYRITHIONE ZINC" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "- for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "- apply only for scalp - apply 2 or 3 times a day with 5~6ml - massage with your finger over 2 min and let them dry" ], "set_id": "a2718e87-6df8-421e-8515-bd77e8a72c0b", "id": "c0cdfc33-66c5-4f25-b2be-73b28f989726", "active_ingredient": [ "active ingredient: biotin" ] }, { "effective_time": "20101119", "inactive_ingredient": [ "Whitening Polish Inactive ingredients water, sorbitol, glycerin. calcium pyrophosphate, hydrated silica, aluminum hydroxide, dicalcium phosphate, flavor, PEG-12, sodium lauryl sulfate, cellulose gum, trisodium phosphate, sodium phosphate, sodium saccharin, titanium dioxide Whitening Paste Inactive ingredients sodium bicarbonate (baking soda), PEG-8, PEG/PPG-116/66 copolymer, sodium carbonate peroxide, tetrasodium pyrophosphate, silica, flavor, water, sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, polyethylene, sucralose, blue 1 lake" ], "purpose": [ "Purpose Whitening Polish Anticavity toothpolish Whitening Toothpaste Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-5135 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "Mentadent Specialty Whitening Toothpaste and Polishing Sodium monofluorophosphate and sodium fluoride Mentadent Toothpolish Sodium Monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION WATER SORBITOL GLYCERIN CALCIUM PYROPHOSPHATE HYDRATED SILICA ALUMINUM HYDROXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE POLYETHYLENE GLYCOL 600 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM PHOSPHATE ION SODIUM PHOSPHATE SACCHARIN SODIUM DIHYDRATE TITANIUM DIOXIDE Mentadent Toothpaste Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOL 400 SODIUM PERCARBONATE SODIUM PYROPHOSPHATE SILICON DIOXIDE WATER SACCHARIN SODIUM DIHYDRATE SODIUM LAUROYL SARCOSINATE SODIUM LAURYL SULFATE POLYETHYLENE GLYCOLS SUCRALOSE FD&C BLUE NO. 1" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or doctor children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Mentadent Speciality Whitening Toothpaste and Polishing Kit Clinically proven to whiten teeth Helps protect surface enamel Strengthens teeth, and fights cavities Refreshing, clean taste CONTENTS: TOOTHPASTE Net wt. 3 oz. (85g) TOOTHPOLISH Net wt. 3 oz. (85g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "a4ce1663-ea5f-404b-b43c-ab2fd9f06f50", "id": "944f9a10-8c94-46f2-9616-89a3b3a17a1e", "active_ingredient": [ "Active ingredients Whitening Polish Sodium monofluorophosphate 0.84% Whitening Toothpaste Sodium Fluoride 0.24%" ] }, { "effective_time": "20120525", "inactive_ingredient": [ "inactive ingredient: water,copper tripeptide, sodium chloride, sodium metasilicate, sodium thiosulfate, sodium carbonate, sodium citrate, citric acid, tetrasodium EDTA" ], "purpose": [ "hair growth, hair loss prevention and scalp protectant" ], "keep_out_of_reach_of_children": [ "keep out of reach of the children" ], "warnings": [ "- keep out of eyes, ears and mouth - if contact occurs, rinse away with plenty of cold water" ], "spl_product_data_elements": [ "HairQ PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM CHLORIDE SODIUM THIOSULFATE SODIUM CARBONATE SODIUM CITRATE CITRIC ACID MONOHYDRATE EDETATE SODIUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "- for external use only" ], "package_label_principal_display_panel": [ "package label" ], "indications_and_usage": [ "- apply only for scalp - apply 2 or 3 times a day with 5~6ml - massage with your finger over 2 min and let them dry" ], "set_id": "ae263d22-c3fb-4ceb-89a1-57878efc5a85", "id": "9a896b34-1e0f-459d-a29c-dc8c1792f268", "active_ingredient": [ "active ingredient: zinc pyrithion" ] }, { "effective_time": "20101116", "inactive_ingredient": [ "Inactive ingredients sodium bicarbonate (baking soda), PEG-8, PEG/PPG-116/66 copolymer, sodium carbonate peroxide, tetrasodium pyrophosphate, silica, flavor, water,sodium saccharin, sodium lauroyl sarcosinate, sodium lauryl sulfate, polyethylene, sucralose, blue 1 lake" ], "purpose": [ "Purpose Anticavity toothpaste" ], "keep_out_of_reach_of_children": [ "Warnings Keep out of reach of children under 6 years of age." ], "warnings": [ "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions or comments? Call 1-800-786-513 5 Monday-Friday 9am-5pm ET" ], "spl_product_data_elements": [ "Mentadent Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BICARBONATE POLYETHYLENE GLYCOL 400 SODIUM PERCARBONATE SODIUM PYROPHOSPHATE SILICON DIOXIDE WATER SACCHARIN SODIUM DIHYDRATE SODIUM LAUROYL SARCOSINATE SODIUM LAURYL SULFATE POLYETHYLENE GLYCOLS SUCRALOSE FD&C BLUE NO. 1" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions supervise children as necessary until capable of using without supervision do not swallow adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician" ], "package_label_principal_display_panel": [ "Principal Display Panel MENTADENT Toothpaste Net wt. 3oz. (85g) Carton image Carton image" ], "indications_and_usage": [ "Use aids in the prevention of dental decay" ], "set_id": "d07632ec-6adb-47e1-9aeb-1b8f6355caf1", "id": "a524ea76-8b98-4849-aab3-85724b72d01b", "active_ingredient": [ "Active ingredients Sodium fluoride (0.24%)" ] }, { "effective_time": "20111206", "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, butylhydroxy toluene, calcium polycarbophil, flavor, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 a Poison Control Center right away." ], "warnings": [ "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." ], "questions": [ "Questions or comments? call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am – 4:30 pm ET) Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108, Made in the U.S.A. ©2008 GlaxoSmithKline" ], "spl_product_data_elements": [ "COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CALCIUM POLYCARBOPHIL MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM speckles (light to dark) speckles (light to dark) NL2U Cappuccino COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CALCIUM POLYCARBOPHIL MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM speckles (light to dark) speckles (light to dark) NL4U Cappuccino" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions 4mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.", "Directions 2mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up , use 4mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up , use 2mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat" ], "spl_unclassified_section": [ "Other information Each lozenge contains: sodium, 18 mg store at 20 – 25 o C (68 – 77 o F) keep POPPAC tightly closed and protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing product" ], "package_label_principal_display_panel": [ "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 4mg STOP SMOKING AID 72 LOZENGES (3 Poppac TM Containers of 24) 4mg EACH FROM THE MARKETERS OF NICORETTE ® NEW CAPPUCCINO FLAVOR Includes User’s Guide CAPPUCCINO FLAVOR 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 Commit ® 2mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit Cappuccino lozenge 4 mg 72 piece carton", "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 2mg STOP SMOKING AID 72 LOZENGES (3 Poppac TM Containers of 24) 2mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide NEW CAPPUCCINO FLAVOR 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 Commit ® 4mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit lozenge cappuccino 2 mg 72 carton" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "dd157bda-6e05-45a5-ae20-e411d2220d11", "id": "1d1cd219-b698-449c-8c5e-92c17f3ccbfd", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg Nicotine polacrilex, 2 mg" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
" ] }, { "effective_time": "20130328", "inactive_ingredient": [ "Inactive ingredients alcohol, benzyl alcohol, flavors, hydroxyethyl cellulose, purified water, simethicone emulsion, sodium carbonate, saccharin sodium, sorbitol solution, xanthan gum" ], "purpose": [ "Active ingredients (in each 5 mL teaspoon) Purposes Calcium carbonate 400 mg Antacid Magnesium hydroxide 135 mg Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you have kidney disease a magnesium-restricted diet. Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks. Keep out of reach of children." ], "questions": [ "Questions or comments? Call 1-800-469-5268 (toll free) or 215-273-8755 (collect)" ], "spl_product_data_elements": [ "MYLANTA Supreme Tasting Calcium Carbonate and Magnesium Hydroxide Calcium Carbonate Carbonate Ion Magnesium Hydroxide Hydroxide Ion alcohol benzyl alcohol water sodium carbonate saccharin sodium sorbitol xanthan gum" ], "ask_doctor": [ "Ask a doctor before use if you have kidney disease a magnesium-restricted diet." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions shake well take 2-4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 18 teaspoonfuls in a 24-hour period, or use the maximum dosage for more than 2 weeks" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if symptoms last more than 2 weeks." ], "storage_and_handling": [ "Other information each teaspoon contains: calcium 164 mg, magnesium 58 mg, sodium 2 mg Do not use if breakaway band on plastic cap is broken or missing Store between 20-25°C(68-77°F) do not freeze" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Calcium carbonate 400 mg Antacid
Magnesium hydroxide 135 mg Antacid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Image not available Principal Display Panel" ], "indications_and_usage": [ "Use relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms overindulgence in food and drink" ], "set_id": "e5ca93de-4c72-44f4-9644-f8f8024121b0", "id": "7b69ff68-33f3-4f6c-97a1-c362112ef992", "purpose_table": [ "
Active ingredients (in each 5 mL teaspoon) Purposes
Calcium carbonate 400 mg Antacid
Magnesium hydroxide 135 mg Antacid
" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist if you are taking a prescription drug. Antacids may interact with certain prescription drugs." ], "active_ingredient": [ "Active ingredients (in each 5 mL teaspoon) Purposes Calcium carbonate 400 mg Antacid Magnesium hydroxide 135 mg Antacid" ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive ingredients acacia, aspartame, calcium polycarbophil, corn syrup solids, flavors, lactose, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, triethyl citrate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 a Poison Control Center right away." ], "warnings": [ "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." ], "questions": [ "Questions or comments? call toll-free 1-888-569-1743 (English/Spanish) (9:00 am – 4:30 pm ET) weekdays Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108, Made in the U.K. ©2008 GlaxoSmithKline" ], "spl_product_data_elements": [ "COMMIT nicotine NICOTINE NICOTINE POLACRILIN ACACIA ASPARTAME CALCIUM POLYCARBOPHIL CORN SYRUP LACTOSE MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE SOY PROTEIN TRIETHYL CITRATE XANTHAN GUM white to off-white NL2S COMMIT nicotine NICOTINE NICOTINE POLACRILIN ACACIA ASPARTAME CALCIUM POLYCARBOPHIL CORN SYRUP LACTOSE MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE SOY PROTEIN TRIETHYL CITRATE XANTHAN GUM white to off-white NL4S" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions 4mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.", "Directions 2mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up , use 4mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up , use 2mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat" ], "spl_unclassified_section": [ "Other information Each lozenge contains: sodium, 18 mg Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge store at 20 – 25 o C (68 – 77 o F) keep POPPAC tightly closed and protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing product" ], "package_label_principal_display_panel": [ "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 4mg STOP SMOKING AID 72 LOZENGES (3 Poppac TM Containers of 24) 4mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide MINT FLAVOR 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 Commit ® 2mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit Mint 4 mg 72 lozenge carton", "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 2mg STOP SMOKING AID 72 LOZENGES (3 Poppac TM Containers of 24) 2mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide MINT FLAVOR 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 Commit ® 4mg Lozenge 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed \"SEALED FOR SAFETY\" is missing or broken. Retain outer carton for full product uses, directions and warnings. COMMIT®, COMMITTED QUITTERS®, POPPAC TM , and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Commit ® POPPAC TM To open vial, push in child resistant band on the POPPAC TM with thumb. Flip up the top of the POPPAC TM and remove lozenge. A small amount of powder on opening of the POPPAC TM is normal. go to www.commitlozenge.com for online support program Commit Mint 2 mg 72 lozenge carton" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "f19946b3-cea7-47ce-9047-9d17ce628600", "id": "a5d0c001-4602-47e0-89b8-4a718389ae15", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg Nicotine polacrilex, 2 mg" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
" ] }, { "effective_time": "20111116", "inactive_ingredient": [ "Inactive ingredients aspartame, calcium polycarbophil, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum" ], "purpose": [ "Purpose Stop smoking aid" ], "keep_out_of_reach_of_children": [ "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 a Poison Control Center right away." ], "warnings": [ "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." ], "questions": [ "Questions or comments? call toll-free 1-888-569-1743 (English/Spanish) weekdays (9:00 am – 4:30 pm ET) 30490IB Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108, Made in the U.K. ©2008 GlaxoSmithKline" ], "spl_product_data_elements": [ "COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ASPARTAME CALCIUM POLYCARBOPHIL MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM white to off-white NL2 COMMIT nicotine polacrilex NICOTINE NICOTINE POLACRILIN ASPARTAME CALCIUM POLYCARBOPHIL MAGNESIUM STEARATE MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE XANTHAN GUM white to off-white NL4" ], "ask_doctor": [ "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" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions 4mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.", "Directions 2mg Lozenge 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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up , use 4mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up , use 2mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 – 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 – 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor." ], "stop_use": [ "Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat" ], "spl_unclassified_section": [ "Other information Each lozenge contains: sodium, 18 mg Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge store at 20 – 25 o C (68 – 77 o F) protect from light" ], "do_not_use": [ "Do not use if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing product" ], "package_label_principal_display_panel": [ "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 4mg STOP SMOKING AID 108 LOZENGES 4mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide ORIGINAL FLAVOR 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 Commit ® 2mg Lozenge 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 This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open or torn. COMMIT®, COMMITTED QUITTERS®, NICORETTE®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. go to www.commitlozenge.com for online support program Commit Original 4 mg 108 lozenge carton", "Principal Display Panel Commit ® Nicotine polacrilex lozenge, 2mg STOP SMOKING AID 108 LOZENGES 2mg EACH FROM THE MARKETERS OF NICORETTE ® Includes User’s Guide ORIGINAL FLAVOR 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 Commit ® 4mg Lozenge 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 This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open or torn. COMMIT®, COMMITTED QUITTERS®, NICORETTE®, and associated logo designs and overall trade dress designs are trademarks owned and/or licensed to GlaxoSmithKline or its affiliated companies. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough – Use at least 9 lozenges of Commit per day during the first six weeks. Use Long Enough – Use Commit for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. go to www.commitlozenge.com for online support program Commit Original 2 mg 108 lozenge carton" ], "indications_and_usage": [ "Uses reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking" ], "set_id": "f60a3194-6b93-4d85-a08d-2d6296f4f9fd", "id": "bc3ca6e0-10c2-41b9-ad16-7a6831ce9d22", "ask_doctor_or_pharmacist": [ "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." ], "active_ingredient": [ "Active ingredient (in each lozenge) Nicotine polacrilex, 4 mg Nicotine polacrilex, 2 mg" ], "dosage_and_administration_table": [ "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
", "
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours
" ] } ] }