{"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"],"ask_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."],"ask_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."],"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. steps"],"effective_time":"20260710","id":"563efbee-122d-62d6-e063-6394a90a2a2b","inactive_ingredient":["Inactive ingredients acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer"],"indications_and_usage":["Use Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking"],"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."],"openfda":{"application_number":["NDA020076"],"brand_name":["Nicotine Transdermal System Patch Step 3","Nicotine Transdermal System Patch Step 2","Nicotine Transdermal System Patch Step 1"],"generic_name":["NICOTINE TRANSDERMAL SYSTEM PATCH"],"is_original_packager":[true],"manufacturer_name":["BluePoint Laboratories"],"nui":["N0000175706","M0014836"],"package_ndc":["68001-699-90","68001-699-88","68001-699-91","68001-698-90","68001-698-88","68001-697-90","68001-697-88"],"pharm_class_cs":["Nicotine [CS]"],"pharm_class_epc":["Cholinergic Nicotinic Agonist [EPC]"],"product_ndc":["68001-697","68001-699","68001-698"],"product_type":["HUMAN OTC DRUG"],"route":["TRANSDERMAL"],"rxcui":["198029","198030","198031"],"spl_id":["563efbee-122d-62d6-e063-6394a90a2a2b"],"spl_set_id":["4856e99a-badc-b957-e063-6294a90a8606"],"substance_name":["NICOTINE"],"unii":["6M3C89ZY6R"]},"package_label_principal_display_panel":["Principal Display Panel STEP 1 NDC 68001-699-88 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. NDC 68001-699-90 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 14 Patches (2 Week Kit) The full treatment course for Step 1 is 28 patches (4 weeks); this package contains 14 patches (2 week course) only. Read the enclosed self-help guide for additional information. NDC 68001-699-91 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 28 Patches (4 Week Kit) The full treatment course for Step 1 is 28 patches (4 weeks). 21mg 7 patches 21 mg 14 Patches 21mg 28 Patches","Principal Display Panel STEP 2 NDC 68001-698-88 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) NDC 68001-698-90 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 14 Patches (2 Week Kit) 14mg 7 Patches 14mg 14 Patches","Principal Display Panel STEP 3 NDC 68001-697-88 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) NDC 68001-697-90 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 14 Patches (2 Week Kit) 7mg 7mg 14 Patches"],"purpose":["Purpose Stop smoking aid"],"questions":["Questions or comments? Call 1-800-585-8682 Weekdays (9am-8pm EST) 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."],"set_id":"4856e99a-badc-b957-e063-6294a90a8606","spl_product_data_elements":["Nicotine Transdermal System Patch Step 1 Nicotine Transdermal System Patch METHACRYLIC ACID NICOTINE NICOTINE Nicotine Transdermal System Patch Step 2 Nicotine Transdermal System Patch METHACRYLIC ACID NICOTINE NICOTINE Nicotine Transdermal System Patch Step 3 Nicotine Transdermal System Patch METHACRYLIC ACID NICOTINE NICOTINE"],"spl_unclassified_section":["Other information store at 20-25°C (68-77°F)"],"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)"],"version":"3","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."],"when_using":["When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime"]}