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spl product data elements
Nicorette 4mg White Ice Mint Gum, Lil Drug Store nicotine polacrilex SUCRALOSE XYLITOL NICOTINE NICOTINE ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM OXIDE STARCH, CORN MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM POLYSORBATE 80 PEPPERMINT OIL SODIUM CARBONATE TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED (white ice mint) (cream) N4
spl unclassified section
Drug Facts Drug Facts
Other information Other information each piece contains: calcium 94 mg, sodium 13 mg store at 20 - 25°C (68 - 77°F) protect from light
Manufactured for: Haleon, Warren, NJ 07059 Made in Sweden ©2023 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies. Packaged and distributed with permission of Haleon by: Lil’ Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 1-877-507-6516 (8AM - 4:30PM CST)
活性成分 / Active ingredient
Active ingredient Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 4 mg nicotine) Purpose Purpose Stop smoking aid
用途 / Purpose
Purpose Purpose Stop smoking aid
适应证 / Indications and usage
Use Use reduces withdrawal symptoms, including nicotine craving,associated with quitting smoking
警告 / Warnings
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 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 a doctor or pharmacist before use 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. Stop use and ask a doctor 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) Keep out of reach of children and pets 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 right away.
咨询医生 / Ask a doctor
Ask a doctor before use 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
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use 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.
停用事项 / Stop use
Stop use and ask a doctor 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)
儿童安全 / Keep out of reach of children
Keep out of reach of children and pets 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 right away.
用法用量原文 / Dosage and administration
Directions Directions 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 border="0" width="100%"><tbody><tr><td>Weeks 1 to 6</td><td>Weeks 7 to 9</td><td>Weeks 10 to 12</td></tr><tr><td>1 piece every 1 to 2 hours</td><td>1 piece every 2 to 4 hours</td><td>1 piece every 4 to 8 hours</td></tr></tbody></table>
辅料 / Inactive ingredients
Inactive ingredients Inactive ingredients acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol
questions
Questions or comments Questions or comments? call toll-free 1-800-419-4766
package label principal display panel
Nicorette 4mg White Ice Mint Gum, Lil' Drug Store ® - PDP/Package This package size may not be a full day’s supply; it is intended to start or continue a quit attempt. Nicorette nicotine polacrilex gum, 4 mg • stop smoking aid Gum [product image] Coated FOR BOLD FLAVOR Whie Ice Mint 4 mg 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 Nicorette 2 mg Gum. 10 PIECES, 4 mg EACH [Lil' Drug Store ® logo] PDP/Package
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20240109
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

