MEMBERS MARK NICOTINE- nicotine polacrilex gum, chewing

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)
Available from:
Sam's West Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stop smoking aid
Authorization status:
Abbreviated New Drug Application
Authorization number:
68196-170-01, 68196-170-06, 68196-170-36, 68196-170-56, 68196-170-70, 68196-170-76

MEMBERS MARK NICOTINE- nicotine polacrilex gum, chewing

Sam's West Inc

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Sam's West, Inc. Nicotine Gum 4 mg Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpos e

Stop smoking aid

Us e

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

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

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

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

using a non-nicotine stop smoking drug

taking prescription medicine for depression or asthma. Your prescription dose may need to be

adjusted.

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)

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).

Directions

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

Other information

Inactive ingredients

acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gum base,

sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc

Questions or comments?

Call 1-866-677-7858 from 7:30 a.m. to 5:00 p.m. Monday-Friday EST.

Consumer Information

Nicotine Polacrilex Gum

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

before using this product, read the enclosed User’s Guide for complete directions and other

important information

begin using the gum on your quit day

if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine

Polacrilex Gum, 2 mg

if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex

Gum, 4 mg according to the following 12 week schedule:

nicotine gum is a medicine and must be used a certain way to get the best results

chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is

gone, begin chewing again, until the tingle returns.

repeat this process until most of the tingle is gone (about 30 minutes)

do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

if you experience strong or frequent cravings, you may use a second piece within the hour.

However, do not continuously use one piece after another since this may cause you hiccups,

heartburn, nausea or other side effects.

do not use more than 24 pieces a day

it is important to complete treatment. If you feel you need to use the gum for a longer period to

keep from smoking, talk to your health care provider.

each piece contains: calcium 100 mg and sodium 11 mg

store at 20-25 C (68-77 F)

protect from light

2 mg and 4 mg User's Guide

How To Use Nicotine Polacrilex Gum To Help You Quit Smoking.

Keys To Success.

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.

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

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

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.

You should continue to use Nicotine Polacrilex Gum as explained in this User's Guide for 12 full

weeks. If you feel you need to use Nicotine Polacrilex Gum for a longer period to keep from

smoking, talk to your health care provider.

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.

If you have trouble using Nicotine Polacrilex Gum, ask your doctor, pharmacist or health care

professional.

To request a free audio CD containing tips to help make quitting easier, call 1-866-677-7858

(ONE CD PER CUSTOMER).

Call your local chapter of the American Lung Association, American Cancer Society or American

Heart Association for further information. Toll free phone numbers are printed on the Wallet Card on

the bottom of this User's Guide.

If you find you cannot stop smoking or if you start smoking again after using 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 on the back of this User's Guide. Carry this card with you. In difficult moments, when you

want to smoke, the card will remind you why you are quitting.

What You're Up Against.

Smoking is addictive in two ways. Your need for nicotine has become both physical and mental. You

must overcome both addictions to stop smoking. So while 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.

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

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

history of seizures

using a non-nicotine stop smoking drug

taking a prescription medicine for depression or asthma. Your prescription dose may need to be

adjusted.

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)

Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make

children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of

overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Let's Get Started.

Becoming a nonsmoker starts today. First, check that you bought the right starting dose. If you smoke

your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg. If you

smoke your first cigarette more than 30 minutes after waking up, 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:

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 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.

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).

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.

End of treatment: The day you'll complete Nicotine Polacrilex Gum therapy.

Identify the date thirteen weeks after the date you chose in Step 1, and place the "EX-SMOKER"

reminder on your calendar.

Plan Ahead.

Because smoking is an addiction, it is not easy to stop. After you've given up cigarettes, you will still

have a strong urge to smoke. Plan ahead NOW for these times, so you're not defeated in a moment of

weakness. The following tips may help:

How Nicotine Polacrilex Gum Works.

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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.

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.

If you are under 18 years of age, ask a doctor before use. Before you can use Nicotine Polacrilex

Gum correctly, you have to practice! That sounds silly, but it isn't. Nicotine Polacrilex Gum isn't like

ordinary chewing gum. It's a medicine, and must be chewed a certain way to work right. Chewed like

ordinary gum, 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.

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

Begin using Nicotine Polacrilex Gum on your quit day.

To reduce craving and other withdrawal symptoms, use Nicotine Polacrilex Gum according to the

dosage schedule on the back of this leaflet.

Chew each Nicotine Polacrilex Gum piece 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.)

"PARK" the Nicotine Polacrilex Gum piece between your cheek and gum, and leave it there.

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.

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

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.)

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

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:

The following tips may help you try to stop Nicotine Polacrilex Gum 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 nonsmoker:

On Your Quit Date:

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.

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.

still feel the need to use Nicotine Polacrilex Gum at the end of week 12 to keep from smoking

start using Nicotine Polacrilex Gum again after stopping

start smoking again

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:

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.

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 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.

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?

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.

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.

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.

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!

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