{"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 our 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":"20260824","id":"ebab2c3a-4fda-40d6-8f54-972e1c6ee69a","inactive_ingredient":["Inactive ingredients - 2 mg carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, xylitol.","Inactive ingredients - 4 mg carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, 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":["ANDA076569"],"brand_name":["Nicotine"],"generic_name":["NICOTINE POLACRILEX"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000175706","M0014836"],"original_packager_product_ndc":["0536-1362"],"package_ndc":["55154-6818-0"],"pharm_class_cs":["Nicotine [CS]"],"pharm_class_epc":["Cholinergic Nicotinic Agonist [EPC]"],"product_ndc":["55154-6818"],"product_type":["HUMAN OTC DRUG"],"route":["BUCCAL"],"rxcui":["314119"],"spl_id":["ebab2c3a-4fda-40d6-8f54-972e1c6ee69a"],"spl_set_id":["ebab2c3a-4fda-40d6-8f54-972e1c6ee69a"],"substance_name":["NICOTINE"],"unii":["6M3C89ZY6R"],"upc":["0055154681803"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-6818-0 NICOTINE POLACRILEX GUM USP, 2 mg (nicotine) stop smoking aid 10 PIECES 2mg bag label"],"purpose":["Purpose Stop smoking aid"],"questions":["Questions or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Overbagged with 10 chewing gum per bag, NDC 55154-6818-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L6156095-10826 / L6156095-20826 Product of United Kingdom PLD-G618C FC009762 Rev. 02/26 R-58 Re-order No. 370061 PLD-G624C FC009805 Rev. 02/26 R-58 Re-order No. 370000"],"questions_table":["
PLD-G618CFC009762Rev. 02/26R-58Re-order No. 370061
PLD-G624CFC009805Rev. 02/26R-58Re-order No. 370000
"],"set_id":"ebab2c3a-4fda-40d6-8f54-972e1c6ee69a","spl_product_data_elements":["Nicotine Nicotine Polacrilex NICOTINE NICOTINE CARNAUBA WAX MAGNESIUM OXIDE SODIUM BICARBONATE SODIUM CARBONATE TALC XYLITOL off-white to tan"],"spl_unclassified_section":["Drug Facts","Other information - 2 mg • each piece contains: calcium 115 mg, sodium 8 mg • store at 20 - 25ºC (68 - 77ºF) • protect from light","Other information - 4 mg • each piece contains: calcium 120 mg, sodium 8 mg • store at 20 - 25ºC (68 - 77ºF) • protect from light","Generic information * This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum. 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 age cannot be verified BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF 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. NICOTINE GUM IMAGE 1 NICOTINE GUM IMAGE 2 NICOTINE GUM IMAGE 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":"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."]}