NICOTINE POLACRILEX GUM- nicotine polacrilex gum, chewing 
Fertin Pharma A/S

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NICOTINE POLACRILEX GUM USP (COATED ICE MINT) - nicotine polacrilex gum, chewing

NICOTINE POLACRILEX GUM USP (COATED ICE MINT)

Nicotine polacrilex gum, chewing

Fertin Pharma A/S

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Use

Warnings

This product is only for those who want to stop smoking.

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

• a sodium-restricted diet

• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.

• high blood pressure not controlled with medication.

Nicotine can increase blood pressure.

• stomach ulcer or diabetes

• history of seizures

Ask a doctor or a 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
  • 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.

Directions

Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12
1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hours

Other information (Coated Ice Mint)

Inactive ingredients (Coated Ice Mint)

each 4 mg piece contains:

acesulfame potassium, calcium carbonate, carnauba wax, coolmix for mint, D&C yellow no. 10, gelatin, gum base, maltitol, menthol, peppermint, sodium carbonate anhydrous, sucralose, titanium dioxide, xylitol

Questions and comments?

Call (800) 601-8328

Additional information found on packaging

Nicotine Polacrilex Gum, USP

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open, or torn.

Distributed by

Fertin Pharma A/S

Dandyvej 19 DK-7100 Vejle,

Denmark

Made in Denmark

For more information see inside for details

June 2020

Nicotine Polacrilex Gum, USP

GUM / COATED / ICE MINT

100 PIECES / 4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use EnoughChew at least 9 pieces of nicotine polacrilex gum USP per day during the first six weeks.
  3. Use Long Enough – Use nicotine polacrilex gum USP for the full 12 weeks.
  4. See Heading 'WHERE TO GET HELP" as directed in the enclosed User's Guide.

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

front-label

NICOTINE POLACRILEX GUM USP (COATED ICE MINT)

Nicotine polacrilex gum, chewing

Fertin Pharma A/S

2 mg and 4 mg User´s Guide

HOW TO USE NICOTINE POLACRILEX GUM USP TO HELP YOU QUIT SMOKING

KEYS TO SUCCESS.

1) You must really want to quit smoking for Nicotine Polacrilex Gum USP to help you.

2) You can greatly increase your chances for success by using at least 9 to 12 pieces every day when you start using Nicotine Polacrilex Gum USP. See chart on back side of User´s Guide.

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

4) Nicotine Polacrilex Gum USP works best when used together with a support program (See Heading “WHERE TO GET HELP.”).

5) If you have trouble using Nicotine Polacrilex Gum USP, ask your doctor or pharmacist or call Fertin Pharma at (800) 601-8328.

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 USP.

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 USP.

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 non-smoker. It will answer common questions about Nicotine Polacrilex Gum USP 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 USP 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 of this User´s Guide.

If you find you cannot stop smoking or if you start smoking again after using Nicotine Polacrilex Gum USP, 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 USP 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 second-hand 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 at the end of this User´s Guide. Carry this card with you. In difficult moments, when you want to smoke, the card will remind you why you are quitting.

WHAT YOU´RE UP AGAINST.

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

SOME IMPORTANT WARNINGS.

This product is only for those who want to stop smoking.

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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.

LET´S GET STARTED.

Becoming a non-smoker starts today. First, check that you bought the right starting dose. If you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum. If you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum. 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 enclosed in this User’s Guide:

Step 1. (Weeks 1-6).

Your quit date (and the day you’ll start using Nicotine Polacrilex Gum USP).

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

Step 2. (Weeks 7-9).

The day you’ll start reducing your use of Nicotine Polacrilex Gum USP.

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

Step 3. (Weeks 10-12).

The day you’ll further reduce your use of Nicotine Polacrilex Gum USP.

Nine weeks after you begin using Nicotine Polacrilex Gum USP, 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 USP every four to eight hours.

End of treatment:

The day you’ll complete Nicotine Polacrilex Gum USP therapy.

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

PLAN AHEAD.

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

HOW NICOTINE POLACRILEX GUM USP WORKS.

Nicotine Polacrilex Gum USP’s sugar-free chewing pieces provide nicotine to your system – they work as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms. Nicotine Polacrilex Gum USP 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 USP 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 USP.

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

1) Begin using Nicotine Polacrilex Gum USP on your quit day.

2) To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum USP according to the dosage schedule below.

3) Chew each Nicotine Polacrilex Gum USP piece very slowly several times.

4) Stop chewing when you notice a peppery taste, or a slight tingling in your mouth. (This usually happens after about 15 chews, but may vary from person to person.)

5) “PARK” the Nicotine Polacrilex Gum USP piece between your cheek and gum, and leave it there.

6) When the peppery taste or tingle is almost gone (in about a minute), start to chew a few times slowly again. When the taste or tingle returns, stop again.

7) Park the Nicotine Polacrilex Gum USP piece again (in a different place in your mouth).

8) Repeat steps 3 to 7 (chew, chew, park) until most of the nicotine is gone from the Nicotine Polacrilex Gum USP piece (usually happens in about half an hour; the peppery taste or tingle won’t return.)

9) Wrap the used Nicotine Polacrilex Gum USP piece in paper and throw away in the trash.

The following chart lists the

recommended usage for Nicotine Polacrilex Gum USP:

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 USP 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 USP USAGE.

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

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

Talk to your doctor or health care provider if you:

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 non-smoker:

On your Quit Date:

Right after Quitting:

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 non-smokers 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 USP 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.

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 non-smoking 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 non-smoker.

QUESTIONS & ANSWERS.

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

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:

Nicotine Polacrilex Gum USP 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 USP just substituting one form of nicotine for another?

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

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

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 in this User’s Guide.

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

The total cost of Nicotine Polacrilex Gum USP 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 USP 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!

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4mg Box Label

63443-5057-1

NICOTINE POLACRILEX GUM, USP

4 mg

Stop smoking aid

COATED ICE MINT

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 Gum USP, 2 mg Gum

100 PIECES, 4 mg EACH

This product is protected in sealed blisters.

Do not use if individual blisters or printed backings are broken, open, or torn.

Distributed by

Fertin Pharma A/S

Dandyvej 19 DK-7100 Vejle,

Denmark

Made in Denmark

Fertin offers a free quit program; please see www.easyquit.dk for details.

November 2022

nicotine-polacrilex-4mg

NICOTINE POLACRILEX GUM 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63443-5057
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
GELATIN (UNII: 2G86QN327L)  
MALTITOL (UNII: D65DG142WK)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeRECTANGLE (RECTANGLE) Size19mm
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63443-5057-110 in 1 CARTON12/21/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21435412/21/2022
Labeler - Fertin Pharma A/S (307046859)

Revised: 1/2023
Document Id: f1773a09-cd15-bc3b-e053-2995a90a683b
Set id: f1774540-7c2f-c60b-e053-2995a90a1ccb
Version: 1
Effective Time: 20230104
 
Fertin Pharma A/S