NDC 46122-568 Nicotine Transdermal System

Nicotine Transdermal System

NDC Product Code 46122-568

NDC 46122-568-07

Package Description: 7 POUCH in 1 CARTON > 1 h in 1 POUCH

NDC Product Information

Nicotine Transdermal System with NDC 46122-568 is a a human over the counter drug product labeled by Amerisourcebergen Drug Corporation. The generic name of Nicotine Transdermal System is nicotine transdermal system. The product's dosage form is patch, extended release and is administered via transdermal form.

Labeler Name: Amerisourcebergen Drug Corporation

Dosage Form: Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nicotine Transdermal System Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NICOTINE 21 mg/24h

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amerisourcebergen Drug Corporation
Labeler Code: 46122
FDA Application Number: ANDA074612 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-02-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nicotine Transdermal System Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Patch)

Step 1 - Nicotine, 21 mg delivered over 24 hoursStep 2 - Nicotine, 14 mg delivered over 24 hoursStep 3 - Nicotine, 7 mg delivered over 24 hours

Purpose

Stop smoking aid

Use

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.

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 drugtaking 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 blood stream 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 rashirregular heartbeat or palpitations occuryou 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 informationbegin using the patch on your quit dayif you smoke more than 10 cigarettes per day, use the following schedule below:Weeks 1 thru 2Weeks 5 and 6Weeks 7 and 8Step 1Step 2Step 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayif you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeksapply one new patch every 24 hours on skin that is dry, clean and hairlessremove 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 dayif you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morningdo not wear more than one patch at a timedo not cut patch in half or into smaller piecesdo not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hoursit is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Other Information

Store at 20° C – 25° C (68° F – 77° F)

Inactive Ingredients

Acrylate adhesive, polyester, silicone adhesive

To Increase Your Success In Quitting:

1. You must be motivated to quit. 2. Use one patch daily according to directions.3. It is important to complete treatment. 4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.5. Use patch with a behavioral support program such as the one described in the enclosed booklet.

User’S Guide

  • BEHAVIOR SUPPORT PROGRAMNicotine Transdermal SystemSTOP SMOKING AID PATCHYour Guide To Help You Successfully Quit SmokingTable of Contents I: Thinking About Quitting Why The Behavior Support Program Leads To Success...............3 Working Towards Success: The Stages Of Change.....................5Which Way Now?.....................................................................8Why I Want To Stop Smoking...................................................8 Health Benefits Of Quitting .......................................................9II: Getting Started: Your Personal Quit Plan Setting Your Quit Date.............................................................10 Understanding Nicotine Addiction..............................................10Smoking And Your Body..........................................................10Smoking And Your Mind...........................................................11Knowing Your "Triggers" ............................................................12Taming Your "Triggers" ..............................................................12Reducing The Urge To Smoke ..................................................12Building Your Supporting Cast...................................................14 Countdown To Quit Day: 10 Steps To Success ..........................14Rewarding Yourself...................................................................16If You Slip ...............................................................................16III: The Patch .Important Information About This Nicotine Transdermal System.....18How The Patch Works..............................................................19How To Use The Patch .............................................................20IV: Weight Control Guide .......................................................27V: You Are On Your Way ........................................................29VI: Your Daily Success Calendar ............................................30VII: Behavior Support Program ..............................................34I: Thinking About QuittingNicotine Transdermal System Patch Stop Smoking AidWhy The Behavior Support Program Leads To Success 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 Behavior 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 Behavior 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 Behavior 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. The 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. Our toll-free telephone support center at 1-844-562-7963, staffed by smoking cessation professionals, will offer you friendly support and information. Call Monday through Friday between 8 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 would like a compact disc, please call 1-844-562-7963.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 6 "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 6 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 1-844-562-7963, 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 1-844-562-7963. 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 1-844-562-7963 can still help you. They can offer you personalized feedback about your smoking, help you set a quit date, assist you 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 who is trying to quit by passing along this information about the Behavior Support Program. Use of 1-844-562-7963 is free of charge.Why I Want To Stop SmokingKnowing 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 betterSense 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. II: Getting Started: Your Personal Quit PlanSetting Your Quit DateNow that you are motivated and committed, the next step is to choose a quit date within the next 2 - 3 weeks. 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 alcoholEnter 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 8 weeks can reduce the withdrawal symptoms you experience. It is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.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 on the next page. 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.

* Please review the disclaimer below.

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