Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

MEIJER NICOTINE TRANSDERMAL SYSTEM STEP 1- nicotine patch, extended release 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient Step 1

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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

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, use nicotine gum, or use another nicotine patch or other nicotine containing products

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.
• an allergy to adhesive tape or have skin problems, because you are more likely to get rashes.

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

When using this product

• do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
• if you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop use and ask a doctor if

• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat

Keep out of reach of children and pets

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

• If you are under 18 years of age, ask a doctor before use
• before using this product, read the enclosed self-help guide for complete directions and other information
• stop smoking completely when you begin using the patch
• if you smoke more than 10 cigarettes per day, use the following schedule below:

• if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
• apply one new patch every 24 hours on skin that is dry, clean and hairless
• remove backing from patch and immediately press onto skin. Hold for 10 seconds.
• wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
• the used patch should be removed and a new one applied to a different skin site at the same time each day
• if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
• do not wear more than one patch at a time
• do not cut patch in half or into smaller pieces
• do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
• to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
• stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Other information

● store at 20-25°C (68-77°F)

USER'S GUIDE

USER’S GUIDE

Nicotine Transdermal System

STOP SMOKING AID PATCH

HABITROL TAKE CONTROL SUPPORT PROGRAM® (with logo)

Your guide to help you successfully quit smoking

Table of Contents

I: Thinking About Quitting

Why the HABITROL Take Control® Support Program Leads to Success ….... 3
Working Towards Success: The Stages of Change ........................................... 5
Which Way Now? ............................................................................................ 8
Why I Want to Stop Smoking ........................................................................... 8
Health Benefits of Quitting ............................................................................... 9

II: Getting Started: Your Personal Quit Plan

Setting Your Quit Date ..................................................................................... 10

Understanding Nicotine Addiction ................................................................... 10

Smoking and Your Body ................................................................................. 10
Smoking and Your Mind ................................................................................. 11
Knowing Your Triggers ................................................................................... 12

Taming Your Triggers ...................................................................................... 12

Reducing the Urge to Smoke ........................................................................... 12

Building Your Supporting Cast ....................................................................... 14

Countdown to Quit Day: 10 Steps to Success ................................................. 15

Rewarding Yourself ....................................................................................... 16

If You Slip ..................................................................................................... 16

III: The Patch

Important Information About this Nicotine Transdermal System ................... 18

How the Patch Works .................................................................................... 19

How to Use the Patch .................................................................................... 20

IV: Weight Control Guide .......................................................................... 27

V: You Are on Your Way ......................................................................... 29

VI: Your Daily Success Calendar ............................................................. 30

VII: HABITROL Take Control® Support Program Resources ............. 34

Congratulations! You’ve joined millions of others who have made the important and rewarding decision to quit smoking. A large percentage of smokers have already successfully quit. You can too. You’ve already taken the first smart step by choosing the patch and the HABITROL Take Control® Support Program. The program includes the use of nicotine replacement therapy and behavioral support, a combination that can significantly increase your chances of quitting. The patch helps smokers quit smoking by reducing nicotine withdrawal symptoms. Many patch users will be able to stop smoking for at least a few days, but many will start smoking again. Most smokers usually have to try to quit several times before they completely stop. Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you. First, there is the 3-step nicotine patch that delivers controlled amounts of nicotine to help reduce your withdrawal cravings for nicotine. The patch utilizes nicotine replacement therapy, and through the use of step-down dosing, gradually reduces the amount of nicotine in your system. Second, the HABITROL Take Control® Support Program, developed by behavioral change and smoking cessation experts, recognizes that quitting smoking is a personal journey that occurs in six stages, known as the “Stages of Change.” The HABITROL Take Control® Support Program offers the following support elements to help you quit:
	1. This guide will teach you how to move through the quit process by helping you to identify your reasons for quitting, manage urges to smoke, recover from slips and control your weight. ; 2. An optional compact disc* gives you more information about the patch and the six “Stages of Change.” It provides guidance about what to do at each stage to increase your chances of quitting for good, as well as, relaxation techniques to help you become and remain smoke-free. It also includes a full track of soothing instrumental music. ; 3. 1-888-HABITROL — our toll-free telephone support center, staffed by smoking cessation professionals, will offer you friendly support and information. Call Monday through Friday between 9 a.m. and 8 p.m. ET. You can use this resource to help you get ready to quit, manage urges, cope with withdrawal symptoms, recover from slips and deal with smoking spouses and friends.
*If you need a cassette tape instead of the compact disc, please call 1-888-HABITROL.
Working Towards Success — The Stages of Change; Quitting smoking is a process that begins long before your quit day. Researchers have determined that smokers go through the following six “Stages of Change” while on the road to becoming smoke-free. Pre-Contemplation Stage: If you are in this stage, you don’t have any intention to quit smoking in the near future (i.e., within the next 6 months). You feel that the benefits you receive from smoking outweigh the costs and risks of smoking. This is called the Pre-Contemplation Stage. If you are in this stage right now, you are not ready to use the patch.
Contemplation Stage: After a period of time, often years, you may begin to realize that you are “hooked,” and that smoking is affecting your health and the health of those around you. You begin to think about the benefits of quitting, but you know that quitting will be difficult. You are seriously considering quitting smoking sometime within the next six months, but you are ambivalent. This is called the Contemplation Stage. In this stage, you may read articles on ways to quit or on the health effects of smoking, while you would have ignored this information in the Pre-Contemplation Stage. You begin to imagine your life without cigarettes. You also begin to experiment with making changes. For example, you may be trying to delay your first cigarette of the day, smoke only half of some cigarettes, or not smoke in your house or car. If you are in this stage right now, you are still not ready to use the patch. Preparation Stage: When you’ve made the decision to quit within the next month, and you have experimented with making changes, you’ve entered the Preparation Stage. Most people who have purchased the patch for the first time are in this stage. Preparation is a good name for this stage because thorough preparation greatly improves your chances of success. Just “winging it” or relying on willpower alone is not enough. You need a game plan that includes setting a quit date and committing to at least one person that you will make this change. Using this guide, as well as talking to the professionals at 1-888-HABITROL, will help you become fully prepared for your quit day and beyond. Action Stage: On the day that you quit smoking, you are in the Action Stage. It’s time to set your plan in motion. You will probably experience cravings for nicotine and urges to have a cigarette throughout the day, but through preparation, you have developed multiple strategies for dealing with your “triggers,” withdrawal symptoms and those cravings or urges to smoke. It’s important to start using the patch on the morning of your quit-day to help reduce urges to smoke and other withdrawal symptoms, such as irritability and difficulty concentrating. Maintenance and Termination Stages: If you are able to remain smoke-free for 6 months, you enter the Maintenance Stage. You like your new life, but still have occasional urges. Watch out for overconfidence. Thinking you can smoke “just one cigarette” should be a blinking neon warning sign. For most people, that one cigarette leads to two, then three, then full-time smoking again. Constantly remind yourself of the benefits you now enjoy as a nonsmoker. Have a plan ready to help you manage unexpected situations that may cause you stress and challenge your resolve to remain smoke-free. Most successful quitters will have occasional urges for many years. Only about 1 in 5 quitters reach the Termination Stage, in which they have absolutely no temptation to smoke, and are 100% confident that they will never smoke again. Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you. Which Way Now? If you are planning on quitting within the next month or have recently quit, continue working through this guide to develop your personal quit plan, including the use of the patch. If you have any questions or need additional support, call the professionals at 1-888-HABITROL. You will be encouraged by the wealth of information and support that is readily available. If you are not planning on quitting soon, this isn’t the time for you to use the patch, but the professionals at 1-888-HABITROL can still help you. They can offer you personalized feedback about your smoking, help you set a quit date, assist with your ambivalence about quitting and provide you information about the resources available to you, even before you’re ready to quit. You can also help a friend or family member that is trying to quit by passing along this information about the HABITROL Take Control® Support Program. Use of 1-888-HABITROL is free of charge. ; Why I Want to Stop Smoking Knowing that there are benefits to quitting is essential to your success. Writing down the reasons you want to quit on a card and keeping it with you to review can help you resist a temptation to smoke. Check off the reasons below that apply to you. □ I want control back — I’m almost always thinking about or smoking a cigarette. I feel like the cigarette is controlling me. □ I want to improve my chances of living a longer, healthier life. □ I want to spend my cigarette money on other things — maybe a vacation. □ I want more time for myself. Instead of taking those smoke breaks outside, I could be doing so many other things. □ I want to look and smell better by getting rid of that lingering odor of smoke. □ I want to set a healthier example for my children and grandchildren. Write other reasons you have for quitting in the space below: ________________________________________________________ ________________________________________________________ ________________________________________________________ ________________________________________________________ ________________________________________________________ ________________________________________________________ After completing this list, refer to it every day to reinforce your commitment to becoming a nonsmoker. Health Benefits of Quitting Most of us recognize the risks of smoking, such as cancer, heart disease and emphysema, but may not be aware of the many immediate and long-term benefits of quitting. Immediate benefits in the first days and months may include: Breathing may get easier Food tastes better Sense of smell improves Walking and exercise may become easier Remember, it’s never too late to quit. Whether you’re 34 or 84, your body can cleanse and start to repair the damage done by years of smoking. Now that you are motivated and committed, the next step is to choose a quit date within the next 2–3 weeks to stop smoking. Decide whether it will be easier to quit on a workday when your smoking may already be restricted, or on the weekend when you are more relaxed. You may want to consider quitting at the beginning of the week, on a Sunday or Monday. It’s best to choose a date when: Your stress level is low You’ll be confronted with a minimum of smoking triggers You will not be in a social situation with other smokers, especially those that include alcohol Enter your quit date on Day 1 of your Daily Success Calendar, located in the back of this guide. Understanding Nicotine Addiction Dependence on cigarettes is a twofold problem: the physical side of addiction to nicotine and the psychological side. Preparing to deal with both in advance will help make quitting easier and more comfortable. Smoking and your body As you know, smoking cigarettes is addictive. Nicotine, the addictive agent, reaches your brain in just seconds after each puff. Your brain and body get used to functioning with a certain level of nicotine. Within a few hours of your last cigarette, your nicotine level drops dramatically, resulting in withdrawal symptoms for most smokers. Common withdrawal symptoms include intense cravings for nicotine, irritability, anxiety, depression, restlessness, difficulty concentrating, difficulty sleeping and increased appetite. Physical withdrawal symptoms usually peak within 24 to 72 hours after quitting, then decline over the next several weeks. Some smokers, however, may experience withdrawal symptoms for several months. Staying on this patch for the full eight weeks can reduce the withdrawal symptoms you experience. Smoking and your mind The physical need for nicotine isn’t the only reason you may find it difficult to quit smoking. You can also be psychologically dependent. Over time you’ve created strong associations or “triggers” to light up a cigarette. Sometimes you smoke for comfort: “Smoking helps me relax,” or “I don’t feel as angry when I smoke.” Sometimes it seems to make a social situation more enjoyable: “I like to smoke when I’m out having coffee with a friend or when drinking at a party.” At other times, you smoke out of habit: “I light up as soon as I get in the car,” “I smoke when I’m taking a break at work” or “Because I am so used to smoking, I feel uncomfortable without a cigarette in my hand.”
Knowing your “triggers” Listed to the right are some of the common situations or activities that “trigger” smoking in many people and some suggestions on how to change your habits in order to reduce your urge to smoke. Taming Your Triggers Here are some other common “triggers.” Check off the ones that apply to you and write down how you will cope in the spaces below. Also, record other personal “triggers” and the things you plan to do instead. Reducing the Urge to Smoke Urges to smoke only last for a few seconds to a few minutes. Believe it or not, the urge to smoke will pass whether you smoke or not. When an urge strikes, try the following: 1. The “Three-Second Breathing” Exercise. Nothing relaxes you more quickly than taking a deep breath. Inhale deeply through pursed lips. Hold your breath for 3 seconds. Then slowly exhale through your mouth.
2. Switch your focus. Deliberately switch your attention from having a cigarette onto something else, like reading or stretching. 3. Use mental imagery to transform the urge into something manageable. For example, imagine the urge to smoke is like feeling thirsty. Then imagine reaching for a glass of cool ice water. Feel the coolness in your throat. Your entire body feels relief. You are calm and the urge has disappeared.
		My Trigger (In the past, I smoked ...)	My Solution (Now, I will ...)
□		To concentrate	_________________________________ _________________________________ _________________________________ ________________________________ _________________________________ _________________________________ _________________________________ _________________________________ _________________________________ _________________________________
□		To relax
□		To give myself a lift
□		Because I was angry
□		Because I was bored
□		Because I felt stressed _________________________________________ _________________________________________

Building Your Supporting Cast

Quitting isn’t easy. Sometimes you can feel all alone. This is where friends and family, both smokers and nonsmokers, can help. Take your friends and family through your quit plan. Once they understand why you are changing some of your old habits, they’ll be in a better position to understand and support you. Tell your smoking friends of your desire to quit (truth is, many of them may have that same desire). You might be pleasantly surprised how supportive they can be. If your smoking friends express an interest in quitting, give them our number, 1-888-HABITROL, and we’ll help get them started. You might even choose to quit at the same time so that you can work as a team supporting one another. It’s hard for people who have never smoked to understand what you’re going through, both emotionally and physically. Be patient with them. Explain that you might be a little (or very) irritable for a while.
Countdown to Quit Day — 10 Steps to Success; 1. Tape a list of your reasons for quitting on the mirror. Go over them daily. 2. Tell one or two friends and your family. Ask for the specific help that you think you will need from each of them. 3. Use the HABITROL Take Control® Support Program. 4. Know your “triggers” and practice your coping strategies. 5. Change your routines (for example, sit in a different chair, not your smoking chair). 6. Plan how you will spend all the money you save from not smoking. 7. Freshen your environment. On the day before your quit date, clean your clothes, car and any rooms where you spend a lot of time. 8. Throw away any remaining cigarettes, ashtrays and lighters the night before your quit day. 9. Have plenty of low-calorie snacks available. 10. Use the patch as directed.; You should not smoke or use any other product containing nicotine while wearing the patch, since doing so will temporarily increase the level of nicotine in your blood. Furthermore, smoking even one cigarette reduces your chances of becoming smoke free. Rewarding Yourself Many people get this far and forget to reward themselves. We know that we are more likely to keep going if we get rewarded. So, in the space below, write ways that you can reward yourself at least once a day.
	——————————————— ——————————————— ——————————————— ——————————————— ——————————————— ——————————————— ———————————————
If You Slip Imagine that you go out with friends and end up having a cigarette. In other words, you “slipped.” This is not a relapse back to smoking. Don’t let this mistake make you feel like a failure or like giving up. Get back on track immediately. Don’t smoke another cigarette. Figure out why you had the slip and how, in the future, you will deal with the people, places or feelings that led to smoking. Do whatever works for you. The point is that slips, like mistakes, can be great learning experiences. If you slip and need help, give us a call at 1-888-HABITROL. We’ll be happy to help you find ways to cope — without a cigarette.; If you resume smoking; If you do return to your regular smoking habit, take some time to examine what went wrong. Did you quit without being prepared? Did you have and use the support of friends and family? If you are ready to try again, we can help you evaluate and revise your personal quit plan: call us at 1-888-HABITROL. The patch helps smokers quit smoking by reducing nicotine withdrawal symptoms. Many patch users will be able to stop smoking for at least a few days, but many will start smoking again. Most smokers usually have to try to quit several times before they completely stop. Your own chances to stop smoking depend on how strongly you are addicted to nicotine, how much you want to quit, and how closely you follow a quitting program like the one that comes with this product. If you find you cannot stop or if you start smoking again after using this product, please talk to a health care professional who can help you find a program that may work better for you. And, if for some reason you are not ready to try again right now, keep these materials until you are ready. Before you set your quit date, call us to help you prepare for a successful quit.
A quick tip -- If you bought a pack of cigarettes to “just have one,” run the rest under cold water and then throw them out! Every single one! Don’t allow yourself to think that you can keep cigarettes stashed away and still resist them. Remember, the only reason to keep cigarettes around is to smoke them!

Inactive ingredients

acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Comments or Questions?

Call 1-800-585-8682 Weekdays (9am-8pm ET)

Step 1 Principal Display

MEIJER NICOTINE TRANSDERMAL SYSTEM  STEP 1
nicotine patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	21 mg

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID (UNII: 1CS02G8656)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-6013-07	7 in 1 CARTON	11/05/2007	03/31/2015
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0067-6013-14	14 in 1 CARTON	11/05/2007	03/31/2015
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020076	11/05/2007	03/31/2015

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 7/2019

Document Id: 5cb3e4a8-14c9-4d65-b20a-f1a372487116

34390-5

Set id: e6681e9d-cde2-4184-b76f-bf7b01a6f8bc

Version: 2

Effective Time: 20190730

 

GlaxoSmithKli