{"active_ingredient":["Active ingredient (in each chewing piece) - 2 mg Nicotine Polacrilex 2 mg (nicotine)","Active ingredient (in each chewing piece) - 4 mg Nicotine Polacrilex 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":["<table><col/><col/><col/><tbody><tr><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 1 to 6 </content></td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 7 to 9</content> </td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 10 to 12 </content></td></tr><tr><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><paragraph>1 piece every  1 to 2 hours </paragraph></td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 piece every  2 to 4 hours </td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 piece every  4 to 8 hours </td></tr></tbody></table>","<table><col/><col/><col/><tbody><tr><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 1 to 6 </content></td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 7 to 9 </content> </td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\"> Weeks 10 to 12 </content></td></tr><tr><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><paragraph>1 piece every  1 to 2 hours </paragraph></td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 piece every  2 to 4 hours </td><td align=\"center\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \">1 piece every  4 to 8 hours </td></tr></tbody></table>"],"effective_time":"20231016","id":"07d76684-6cb2-a4d4-e063-6394a90a2042","inactive_ingredient":["Inactive ingredients - 2 mg acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, 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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL DRUG: Nicotine Polacrilex GENERIC: Nicotine Polacrilex DOSAGE: GUM, CHEWING ADMINSTRATION: BUCCAL NDC: 70518-2844-0 COLOR: pink FLAVOR: CINNAMON SHAPE: SQUARE SCORE: No score SIZE: 14 mm PACKAGING: 1 in 1 BLISTER PACK OUTER PACKAGING: 100 in 1 CARTON ACTIVE INGREDIENT(S): NICOTINE 4mg in 1 INACTIVE INGREDIENT(S): ACACIA ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CARNAUBA WAX FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL Remedy_Label"],"purpose":["Purpose Stop smoking aid"],"questions":["Questions or comments? Call 1-800-645-2158"],"set_id":"066cc0a4-b647-4b28-9015-36e7bd6d0bce","spl_product_data_elements":["Nicotine Polacrilex Nicotine Polacrilex ACACIA ACESULFAME POTASSIUM BUTYLATED HYDROXYTOLUENE CARNAUBA WAX FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE, UNSPECIFIED SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE 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, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol."],"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":"2","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."]}