{"active_ingredient":["Active ingredient (in each patch) Nicotine, 21 mg delivered over 24 hours","Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours","Active ingredient (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: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day 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 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."],"dosage_and_administration_table":["
Weeks 1 thru 4Weeks 5 and 6 Weeks 7 and 8
Step 1Step 2Step 3
use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day
"],"effective_time":"20251118","id":"43e1a5a7-e10f-afa8-e063-6294a90a254e","inactive_ingredient":["Inactive ingredients acrylate adhesive, polyester, silicone adhesive"],"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":["ANDA074612"],"brand_name":["Nicotine Transdermal System"],"generic_name":["NICOTINE TRANSDERMAL SYSTEM"],"is_original_packager":[true],"manufacturer_name":["Aveva Drug Delivery Systems, Inc."],"nui":["N0000175706","M0014836"],"package_ndc":["3215-0122-14","3215-0121-14","3215-0120-14"],"pharm_class_cs":["Nicotine [CS]"],"pharm_class_epc":["Cholinergic Nicotinic Agonist [EPC]"],"product_ndc":["3215-0120","3215-0122","3215-0121"],"product_type":["HUMAN OTC DRUG"],"route":["TRANSDERMAL"],"rxcui":["198029","198030","198031"],"spl_id":["43e1a5a7-e10f-afa8-e063-6294a90a254e"],"spl_set_id":["55442645-fa9b-4a9b-81e2-345ad062a124"],"substance_name":["NICOTINE"],"unii":["6M3C89ZY6R"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg 14 CARTON NDC 3215-0122-14 Nicotine Nicotine Transdermal System 21 mg delivered over 24 hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS Includes Behavior Support Program with Self-help Guide 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. STEP 1 21 mg 14 clear patches (2 week kit) COMPARE TO HABITROL ® active ingredient* 21 mg, 14's CARTON","PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON NDC 3215-0121-14 Nicotine Nicotine Transdermal System 14 mg delivered over 24 hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS Includes Behavior Support Program with Self-help Guide 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. STEP 2 14 mg 14 clear patches (2 week kit) COMPARE TO HABITROL ® active ingredient* 14 mg CARTON","PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON NDC 3215-0120-14 Nicotine Nicotine Transdermal System 7 mg delivered over 24 hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS Includes Behavior Support Program with Self-help Guide For use after completing step 2 STEP 3 7 mg 14 clear patches (2 week kit) COMPARE TO HABITROL ® active ingredient* 7 mg CARTON"],"pregnancy_or_breast_feeding":["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."],"purpose":["Purpose Stop smoking aid"],"questions":["Questions or comments? 1-888-889-8893"],"set_id":"55442645-fa9b-4a9b-81e2-345ad062a124","spl_product_data_elements":["Nicotine Transdermal System Nicotine Transdermal System DIMETHICONE NICOTINE NICOTINE Nicotine Transdermal System Nicotine Transdermal System DIMETHICONE NICOTINE NICOTINE Nicotine Transdermal System Nicotine Transdermal System DIMETHICONE NICOTINE NICOTINE"],"spl_unclassified_section":["Drug Facts","Other information store at 20°C-25°C (68°F-77°F)","TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use one patch daily according to directions. 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. Use patch with a behavioral support program, such as the one described in the enclosed booklet.","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. For your family’s protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn. See bottom panel for lot number and expiration date See self-help guide inside. *This product is not manufactured or distributed by Dr. Reddy's Laboratories Ltd.,owner of the registered trademark Habitrol ® .","Mfd. by: AVEVA DRUG DELIVERY SYSTEMS A DifGen Company Miramar, FL 33025 MADE IN USA Rev. 05/2025 1003691 1003690 1003689"],"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 rash irregular 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":"1","warnings":["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. 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 the 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 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 the patch at bedtime"]}