{"active_ingredient":["Active ingredient Step One (in each patch) Nicotine, 21 mg delivered over 24 hours","Active ingredient Step Two (in each patch) Nicotine, 14 mg delivered over 24 hours","Active ingredient Step Three (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 skin problems because you are more likely to get rashes."],"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 used patch 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 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
"],"effective_time":"20250730","id":"3b272bb9-e522-8dfa-e063-6294a90a18cc","inactive_ingredient":["Inactive ingredients acrylate adhesive, polyester, silicone adhesive"],"indications_and_usage":["Uses 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 used patch by folding sticky ends together and putting in pouch."],"openfda":{"application_number":["ANDA074612"],"brand_name":["Nicotine"],"generic_name":["NICOTINE"],"is_original_packager":[true],"manufacturer_name":["Strategic Sourcing Services LLC"],"nui":["N0000175706","M0014836"],"package_ndc":["70677-0031-1","70677-0030-1","70677-0032-1"],"pharm_class_cs":["Nicotine [CS]"],"pharm_class_epc":["Cholinergic Nicotinic Agonist [EPC]"],"product_ndc":["70677-0032","70677-0031","70677-0030"],"product_type":["HUMAN OTC DRUG"],"route":["TRANSDERMAL"],"rxcui":["198029","198030","198031"],"spl_id":["3b272bb9-e522-8dfa-e063-6294a90a18cc"],"spl_set_id":["a08022ff-e412-47f9-8132-318f55528c5c"],"substance_name":["NICOTINE"],"unii":["6M3C89ZY6R"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON Principal Display Panel - Step 1 – 21 mg Carton Label McKesson SunMark ® NDC 70677-0032-1 COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®* Clear Nicotine Transdermal System 21 mg delivered over 24 hours STOP SMOKING AID 21 mg Includes Behavior Support Program with Self-Help Guide STEP ONE 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 *Habitrol® is a registered trademark of Novartis Consumer Health, Inc. nicotine-transdermal-system-one-carton.jpg","PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON Principal Display Panel - Step 2 – 14 mg Carton Label McKesson SunMark ® NDC 70677-0031-1 COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®* Clear Nicotine Transdermal System 14 mg delivered over 24 hours STOP SMOKING AID 14 mg Includes Behavior Support Program with Self-Help Guide STEP ONE 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 *Habitrol® is a registered trademark of Novartis Consumer Health, Inc. nicotine-transdermal-system-two-carton.jpg","PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON Principal Display Panel - Step 3 – 7 mg Carton Label McKesson SunMark ® NDC 70677-0030-1 COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®* Clear Nicotine Transdermal System 7 mg delivered over 24 hours STOP SMOKING AID 7 mg Includes Behavior Support Program with Self-Help Guide STEP ONE 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 *Habitrol® is a registered trademark of Novartis Consumer Health, Inc. nicotine-transdermal-system-three-carton.jpg"],"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"],"set_id":"a08022ff-e412-47f9-8132-318f55528c5c","spl_product_data_elements":["Nicotine Nicotine DIMETHICONE NICOTINE NICOTINE Nicotine Nicotine DIMETHICONE NICOTINE NICOTINE Nicotine Nicotine DIMETHICONE NICOTINE NICOTINE"],"spl_unclassified_section":["Drug Facts","Other information Store at 20°C-25°C (68°F-77°F)","Comments or questions? 1-844-562-7963","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."],"stop_use":["Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or 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"],"version":"10","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 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 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 used patch by folding sticky ends together and putting in pouch."],"when_using":["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"]}