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| Product NDC Code | 56062-503 | ||||
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| Drug Name | Nicotine polacrilex coated fruit |
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| Type | Brand | ||||
| Pharm Class | Cholinergic Nicotinic Agonist [EPC], Nicotine [CS] |
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| Active Ingredients |
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| Route | BUCCAL | ||||
| Dosage Form | GUM, CHEWING | ||||
| RxCUI drug identifier | 311975, 314119 |
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| Application Number | ANDA079044 | ||||
| Labeler Name | Publix Supermarkets, Inc. | ||||
| Packages |
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| 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 2 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.
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| 1 piece every 1 to 2 hours | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
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| 1 piece every 1 to 2 hours | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
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 and 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 and 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 coated fruit Nicotine Polacrilex Coated Fruit Nicotine Polacrilex NICOTINE NICOTINE ACACIA ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 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 tan coated fruit
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 the active ingredient in Nicorette® Gum SUGAR FREE nicotine gum NICOTINE POLACRILEX GUM USP, 2 mg (nicotine) STOP SMOKING AID COATED FRUIT FLAVOR 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, 4 mg 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 Long 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 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 protect. Do not use if individual seals are open or torn. *This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Gum. DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY, LAKELAND,FL 33811, 1-888-267-3037
Package label 2 mg PUBLIX Sugar Free Nicotine Coated Fruit Flavor Nicotine Polacrilex 2 mg (nicotine)
Principal display panel 4 mg *Compare to the active ingredient in Nicorette® Gum SUGAR FREE nicotinegum NICOTINE POLACRILEX GUM USP, 4 mg (nicotine) STOP SMOKING AID COATED FRUIT FLAVOR FOR THOSE 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 4 mg TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivates 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. *This product is not manufactured or distributed by Haleon group of companies, Distributor of Nicorette® Gum DISTRIBUTED BY PUBLIX SUPERMARKETS, INC., 3300 PUBLIX CORPARATE PARKWAY, LAKELAND, FL 33811, 1-888-267-3037
Package label 4 mg PUBLIX nicotine Polacrilex Coated Fruit Flavor Nicotine Polacrilex 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
Active ingredient (in each chewing piece) - 4 mg Nicotine Polacrilex 4 mg (nicotine)
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 - 25°C (68 - 77°F) 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.
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