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spl product data elements
Habitrol Step 1 Nicotine Transdermal System Patch NICOTINE NICOTINE Methacrylic Acid Habitrol Step 2 Nicotine Transdermal System Patch NICOTINE NICOTINE Methacrylic Acid Habitrol Step 3 Nicotine Transdermal System Patch NICOTINE NICOTINE Methacrylic Acid steps 21mg 7ct carton 14mg 7ct carton 7mg 7ct carton
活性成分 / Active ingredient
Active ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours
Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours
Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours
用途 / Purpose
Purpose Stop smoking aid
适应证 / Indications and usage
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
警告 / Warnings
WARNINGS SECTION 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. •stomach ulcer or diabetes.history of seizures. 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 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 occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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 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.
咨询医生 / Ask a doctor
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. •stomach ulcer or diabetes.history of seizures.
咨询医药人员 / Ask a doctor or pharmacist
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.
使用中 / When using
When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime
停用事项 / Stop use
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 occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)
儿童安全 / Keep out of reach of children
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.
用法用量原文 / Dosage and administration
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 • begin using the patch on your quit day • 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 • 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 • 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.
spl unclassified section
Other information store at 20-25°C (68-77°F)
辅料 / Inactive ingredients
Inactive ingredients acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
questions
Questions or comments? call 1-800-585-8682 Weekdays (9am-8pm ET) or visit us at www.habitrol.com 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 behavioural support program, such as the one described in the enclosed booklet. For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn. • Not for sale to persons 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.
package label principal display panel
Principal Display Panel STEP 1 NDC 55741-448-74 Habitrol ® Nicotine Transdermal System Patch 21 mg delivered over 24 hours STOP SMOKING AID 21 mg Includes: Behavior Support Program with self-help guide STEP 1 IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: START WITH STEP 1 IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2 7 Patches (1 Week Kit) The full treatment course for Step 1 is 28 patches (4 weeks); this package contains 7 patches (1 week course) only. Read the enclosed self-help guide for additional information.
Principal Display Panel STEP 2 NDC 55741-447-74 Habitrol ® Nicotine Transdermal System Patch 14 mg delivered over 24 hours STOP SMOKING AID 14 mg Includes: Behavior Support Program with self-help guide STEP 2 IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: USE AFTER COMPLETING STEP 1 IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2 7 Patches (1 Week Kit)
Principal Display Panel STEP 3 NDC 55741-446-74 Habitrol ® Take Control™ Support Program Nicotine Transdermal System Patch 7 mg delivered over 24 hours STOP SMOKING AID 7 mg Includes: Behavior Support Program with self-help guide STEP 3 FOR USE AFTER COMPLETING STEP 2 7 Patches (1 Week Kit)
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 12 / 20240725
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

