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| Product NDC Code | 0135-0511 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Nicorette |
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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 | ORAL | ||||||||
| Dosage Form | LOZENGE | ||||||||
| RxCUI drug identifier | 359817, 359818, 968849, 968851 |
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| Application Number | NDA021330 | ||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||
| 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 lozenge) (2 mg) Nicotine polacrilex, 2 mg
Active ingredient (in each lozenge) (4 mg) Nicotine polacrilex, 4 mg
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. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 - 30 minutes). Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 - 30 minutes) do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. it is important to complete treatment. If you feel you need to use the lozenge 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 acacia, aspartame, calcium polycarbophil, corn syrup solids, flavors, lactose, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, soy protein, triethyl citrate, xanthan gum
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.NICORETTE nicotine polacrilex POLACRILIN ACACIA ASPARTAME CALCIUM POLYCARBOPHIL CORN SYRUP LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE SOY PROTEIN TRIETHYL CITRATE XANTHAN GUM NICOTINE NICOTINE NL2S white to off-white NICORETTE nicotine polacrilex POLACRILIN ACACIA ASPARTAME CALCIUM POLYCARBOPHIL CORN SYRUP LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MANNITOL POTASSIUM BICARBONATE SODIUM ALGINATE SODIUM CARBONATE SOY PROTEIN TRIETHYL CITRATE XANTHAN GUM NICOTINE NICOTINE white to off-white NL4S
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 NDC 0135-0510-07 Nicorette ® nicotine polacrilex lozenge, 2 mg stop smoking aid Lozenge Includes User’s Guide 2mg 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 Nicorette 4 mg Lozenge Mint 144 Lozenges, 2 mg Each (6 POPPAC ® Containers of 24) 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed “SEALED FOR SAFETY” is missing or broken. Retain outer carton for full product uses, directions and warnings. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough - Use at least 9 Nicorette ® Lozenges per day during the first six weeks. Use Long Enough - Use Nicorette ® Lozenges for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Nicorette ® POPPAC ® To open vial, push in child resistant band on the POPPAC ® container with thumb. Flip up the top of the POPPAC ® and remove lozenge. A small amount of powder on opening of the POPPAC ® is normal. For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details. Trademarks are owned by or licensed to the GSK group of companies. Distributed By: GSK Consumer Healthcare Warren, NJ 07059 Made in Switzerland Made in the Switzerland ©2015 GSK group of companies or its licensor. All rights reserved. 104959XC Nicorette Lozenge Mint 2mg 144 count carton
Principal Display Panel NDC 0135-0511-07 Nicorette ® nicotine polacrilex lozenge, 4 mg stop smoking aid Lozenge Includes User’s Guide 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 Lozenge Mint 144 Lozenges, 4 mg Each (6 POPPAC ® Containers of 24) 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 TAMPER EVIDENT FEATURE: Do not use if clear neckband printed “SEALED FOR SAFETY” is missing or broken. Retain outer carton for full product uses, directions and warnings. TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Use Enough - Use at least 9 Nicorette ® Lozenges per day during the first six weeks. Use Long Enough - Use Nicorette ® for the full 12 weeks. Use With a Support Program as directed in the enclosed User’s Guide. Nicorette ® POPPAC ® To open vial, push in child resistant band on the POPPAC ® container with thumb. Flip up the top of the POPPAC ® and remove lozenge. A small amount of powder on opening of the POPPAC ® is normal. For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details. Trademarks are owned by or licensed to the GSK group of companies. Distributed By: GSK Consumer Healthcare Warren, NJ 07059 Made in the Switzerland ©2015 GSK group of companies or its licensor. All rights reserved. 104960XC Nicorette Lozenge Mint 4mg 144 count carton
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 your 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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use (Mint) if you are allergic to soya
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. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll-free 1-888-569-1743
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 problems occur persistent indigestion or severe sore throat occurs 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)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information each lozenge contains: sodium, 18 mg Phenylketonurics: Contains Phenylalanine 3.4 mg per lozenge store at 20 - 25°C (68 - 77°F) keep POPPAC tightly closed and protect from light
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. Do not use (Mint) if you are allergic to soya 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 your blood pressure. stomach ulcer or diabetes history of seizures 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. Stop use and ask a doctor if mouth problems occur persistent indigestion or severe sore throat occurs 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. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.
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