Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 70000-0342 | ||||
|---|---|---|---|---|---|
| Drug Name | Nicotine polacrilex coated fruit |
||||
| Type | Brand | ||||
| Pharm Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
||||
| Active Ingredients |
|
||||
| Route | BUCCAL | ||||
| Dosage Form | GUM, CHEWING | ||||
| RxCUI drug identifier | 311975, 314119 |
||||
| Application Number | ANDA079038 | ||||
| Labeler Name | Cardinal Health (Leader) 70000 | ||||
| Packages |
|
||||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.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)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients - 2 mg acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.
Inactive ingredients - 4 mg acacia, acesulfame potassium, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose
Information about the drug product’s indications for use.Purpose Stop smoking aid
Spl product data elements
Usually a list of ingredients in a drug product.Nicotine Polacrilex Coated Fruit Nicotine Polacrilex NICOTINE NICOTINE ACACIA ACESULFAME POTASSIUM CARNAUBA WAX FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM OXIDE SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL light brown Nicotine Polacrilex Coated Fruit Nicotine Polacrilex NICOTINE NICOTINE ACACIA ACESULFAME POTASSIUM CARNAUBA WAX FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM OXIDE SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TALC TITANIUM DIOXIDE XYLITOL D&C YELLOW NO. 10 light tan
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal display panel 2 mg COMPARE TO NICORETTE® FRUIT CHILL® GUM active ingredient Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 2 mg (nicotine) Stop Smoking Aid 2 mg Coated Fruit Flavor ForThose 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 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 weweks. 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 *This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum. BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com
Package label 2 mg LEADER Sugar Free Nicotine Gum Coated Fruit Flavor Nicotine Polacrilex (equal to 2 mg nicotine)
Principal display panel 4 mg COMPARE TO NICORETTE® FRUIT CHILL® GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (Nicotine) Stop Smoking Aid 4 mg Coated Fruit Flavor 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 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 Lone Enough - Use Nicotine Polacrilex for the full 12 weeks 4. Use With a Support Program as directed in the enclosed User's Guide. not for sale to those 18 years of age proog of age is required not for sale in vending machines or from any source where proof of age be verified *This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum. BLISTER PACKAGED OR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN . DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
Package label 4 mg LEADER Sugar Free Nicotine Gum Coated Fruit Flavor Nicotine Polacrilex (equal to 4 mg nicotine)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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 115 mg, sodium 8 mg store at 20 - 25ºC (68 - 77ºF) protect from light
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question or comments? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API