CVS Pharmacy, Inc. Nicotine Polacrilex Lozenge 4 mg (nicotine) Drug Facts

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 4 mg (nicotine)

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you . • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • 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. 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 • 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. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other information

STORAGE AND HANDLING SECTION

• store at 20-25°C (68-77°F) • keep vial tightly closed and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, calcium polycarbophil, magnesium stearate, mannitol, natural and artificial mint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-866-751-9303

Consumer Information

SPL UNCLASSIFIED SECTION

Nicotine Polacrilex Lozenge 2 mg and 4 mg User's Guide mini Lozenge How to Use Mini 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. Mini Nicotine Polacrilex Lozenges can help if you really want to quit. Mini 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 mini Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on a regular schedule (as outlined in this User's Guide). 3) Start using mini Nicotine Polacrilex Lozenges on your quit date. 4) This User's Guide outlines a 12-week plan for mini 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. Even a single cigarette can put you right back to square one. 5) Mini Nicotine Polacrilex Lozenges work best when used together with a support plan. See information to the right for instructions on enrollment in the SmokeFreeHabits.com Free & Personalized Support Plan. 6) After the first six weeks, start using fewer mini Nicotine Polacrilex Lozenges, as directed in the instructions, gradually reducing your use over the next six weeks. If you feel the need to use the lozenges for a longer period to keep from smoking, talk to your health care provider. 7) If you have questions about using mini 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 mini Nicotine Polacrilex Lozenges to help you, you're starting on the right path. Now remember, using mini Nicotine Polacrilex Lozenges doesn't just mean taking a mini 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 mini 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 on the bottom 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 bottom 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. Mini 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. Ask a doctor before use if you have • 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. • history of seizures Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor if • mouth 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 • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 4 mg mini Nicotine Polacrilex Lozenges. If you smoke your first cigarette more than 30 minutes after waking up, use the 2 mg mini Nicotine Polacrilex Lozenges. Next, plan your quitting schedule. Get a calendar to follow your progress and mark the following four important dates (see the reminders on the left side of this leaflet). THE PROGRAM STEP 1. (Weeks 1-6) Starting on your quit date it's best to use at least 9 mini 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 reminder on this date. That's the day you will start using mini 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 mini 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. 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. Remember to read the USING mini Nicotine Polacrilex LOZENGES PROPERLY section before you take your first mini Nicotine Polacrilex Lozenge. STEP 2. (The next three weeks, that is weeks 7-9). At the beginning of week 7 start using fewer mini Nicotine Polacrilex Lozenges, one every 2-4 hours. After six weeks, you should wait a little longer betw...

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health ® Compare to the active ingredient in Nicorette ® Mini Lozenge Sugar Free SEE NEW WARNINGS 4 mg Nicotine Lozenge Nicotine Polacrilex Lozenge 4 mg (nicotine) STOP SMOKING AID FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP. If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Lozenge, 2 mg. Actual Size Mint Mini Lozenge 81 LOZENGES, 4 mg EACH (3 CONTAINERS OF 27) Includes User’s Guide