{"active_ingredient":["Active ingredient (in each chewing piece) - 2 mg Nicotine polacrilex (equal to 2 mg nicotine)","Active ingredient (in each chewing piece) - 4 mg Nicotine polacrilex (equal to 4 mg nicotine)"],"ask_doctor":["Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase blood pressure. 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted."],"dosage_and_administration":["Directions - 2 mg if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.","Directions - 4 mg if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours 1 piece every 2 to 4 hours 1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns. repeat this process until most of the tingle is gone (about 30 minutes) do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider."],"dosage_and_administration_table":["
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 piece every 1 to 2 hours1 piece every 2 to 4 hours 1 piece every 4 to 8 hours
","
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
1 piece every 1 to 2 hours1 piece every 2 to 4 hours 1 piece every 4 to 8 hours
"],"effective_time":"20260714","id":"3f003626-da26-4e6c-9e31-edbd35c2d5b4","inactive_ingredient":["Inactive ingredients - 2 mg acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40 lake, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol."],"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. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA079216","ANDA079219"],"brand_name":["Nicotine"],"generic_name":["NICOTINE POLACRILEX"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"nui":["N0000175706","M0014836"],"package_ndc":["0536-3404-25","0536-3404-37","0536-3404-01","0536-3405-25","0536-3405-37","0536-3405-01"],"pharm_class_cs":["Nicotine [CS]"],"pharm_class_epc":["Cholinergic Nicotinic Agonist [EPC]"],"product_ndc":["0536-3404","0536-3405"],"product_type":["HUMAN OTC DRUG"],"route":["BUCCAL"],"rxcui":["311975","314119"],"spl_id":["3f003626-da26-4e6c-9e31-edbd35c2d5b4"],"spl_set_id":["d67149d5-4766-4b84-8205-f1a6b692f4c9"],"substance_name":["NICOTINE"],"unii":["6M3C89ZY6R"]},"package_label_principal_display_panel":["Principal display panel 2 mg compare to the active ingredient in Nicorette® Gum* Nicotine Gum nicotine polacrilex gum USP, 2 mg (Nicotine) stop smoking aid 2 mg Coated Cinnamon Flavor sugar-free FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Gum USP, 4 mg","Package label 2 mg RUGBY Sugar Free Nicotine Polacrilex Coated Cinnamon Flavor Nicotine Polacrilex (equal to 2 mg nicotine)","Principal display panel 4 mg compare to the active ingredient in Nicorette® Gum* nicotine gum nicotine polacrilex gum USP, 4 mg (Nicotine) stop smoking aid 4 mg Coated Cinnamon Flavor Sugar-Free FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Gum USP, 2 mg","Package label 4 mg RUGBY Sugar Free Nicotine Polacrilex Coated Cinnamon Flavor Nicotine Polacrilex (equal to 4 mg nicotine)"],"purpose":["Purpose Stop smoking aid"],"questions":["Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"d67149d5-4766-4b84-8205-f1a6b692f4c9","spl_product_data_elements":["Nicotine Nicotine Polacrilex NICOTINE NICOTINE ACACIA ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CARNAUBA WAX FD&C RED NO. 40 ALUMINUM LAKE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL light pink Nicotine Nicotine Polacrilex NICOTINE NICOTINE ACACIA ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CARNAUBA WAX FD&C RED NO. 40 ALUMINUM LAKE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL dark pink"],"spl_unclassified_section":["Drug Facts","Other information - 2 mg each piece contains: calcium 115 mg, sodium 11 mg store at 20 - 25ºC (68 - 77ºF) protect from light","Other information - 4 mg each piece contains: calcium 115 mg, sodium 11 mg store at 20 - 25ºC (68 - 77ºF) protect from light","Inactive ingredients - 4 mg acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40 lake, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.","Consumer Information TO INCREASE YOUR SUCCESS IN QUITTING : 1. You must be motivated to quit. 2 Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks. 3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks. 4. Use With a Support Program as directed in the enclosed User's Guide. not for sale to those under 18 years of age proof of age required not for sale in vending machines or from any source where proof of sge csnnot be verified *This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum. BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE INDIVIDUAL SEALS ARE OPEN OR TORN Gum image 1 Gum image 2 Gum image 3 1. To remove the gum, tear off single unit 2. Peel off backing starting at corner with loose edge 3. Push gum through foil FC009742 2 mg Rev.02/26 R-58 Re-order No. 370118 FC009771 4 mg Rev. 02/26 R-58 Re-order No. 370123 Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Nicotine gum 1 Nicotine gum 2 Nicotine gum 3"],"stop_use":["Stop use and ask a doctor if mouth, teeth, or jaw problems occur irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)"],"version":"22","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."]}