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| Product NDC Code | 0135-0466 | ||||||||||||||
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| Drug Name | Nicorette cinnamon surge |
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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 | GUM, CHEWING | ||||||||||||||
| Application Number | NDA018612 | ||||||||||||||
| 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 chewing piece) Nicotine polacrilex (equal to 2 mg nicotine) 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 (White Ice Mint) each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol each 4 mg piece contains: 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
Inactive ingredients (Original) each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol
Inactive ingredients (Cinnamon Surge) each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol
Inactive ingredients (Mint) each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol
Inactive ingredients (Spearmint Burst) each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, 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.Nicorette White Ice Mint nicotine polacrilex POLACRILIN ACESULFAME POTASSIUM CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE N2 White Ice Mint Nicorette White Ice Mint nicotine polacrilex POLACRILIN ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE cream N4 White Ice Mint Nicorette Original nicotine polacrilex POLACRILIN GLYCERIN SODIUM BICARBONATE SODIUM CARBONATE SORBITOL NICOTINE NICOTINE beige Nicorette Original nicotine polacrilex POLACRILIN D&C YELLOW NO. 10 GLYCERIN SODIUM CARBONATE SORBITOL NICOTINE NICOTINE beige Nicorette Cinnamon Surge nicotine polacrilex POLACRILIN ACACIA ACESULFAME POTASSIUM CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE N2 Nicorette Cinnamon Surge nicotine polacrilex POLACRILIN ACACIA ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE cream N4 Nicorette Mint nicotine polacrilex POLACRILIN ACESULFAME POTASSIUM MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL SODIUM BICARBONATE SODIUM CARBONATE XYLITOL NICOTINE NICOTINE beige Nicorette Mint nicotine polacrilex POLACRILIN ACESULFAME POTASSIUM D&C YELLOW NO. 10 ALUMINUM OXIDE MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL SODIUM CARBONATE XYLITOL NICOTINE NICOTINE beige Nicorette Spearmint Burst nicotine polacrilex POLACRILIN ACACIA ACESULFAME POTASSIUM CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM BICARBONATE SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE beige N2 Nicorette Spearmint Burst nicotine polacrilex POLACRILIN ACACIA ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE N4 Nicorette Spearmint Burst nicotine polacrilex POLACRILIN ACACIA ACESULFAME POTASSIUM CARNAUBA WAX D&C YELLOW NO. 10 HYPROMELLOSE, UNSPECIFIED MAGNESIUM OXIDE MENTHOL, UNSPECIFIED FORM PEPPERMINT OIL POLYSORBATE 80 SODIUM CARBONATE SUCRALOSE TITANIUM DIOXIDE XYLITOL NICOTINE NICOTINE N4
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 0135-0474-02 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 2 mg 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 Gum COATED FOR BOLD FLAVOR 100 PIECES, 2 mg EACH White Ice Mint 824747 Front Label 824747 Nicorette White Ice Mint 2 mg_100 ct.jpg
Principal Display Panel NDC 0135-0475-02 HALEON NICORETTE nicotine polacrilex gum, 4 mg stop smoking aid Gum 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. COATED FOR BOLD FLAVOR 100 PIECES, 4 mg EACH White Ice Mint 824750 Front Label 824750 Nicorette White Ice Mint 4 mg_100 ct.jpg
Principal Display Panel NDC 0135-0157-11 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 2 mg 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 Gum 200 PIECES, 2 mg EACH Original 824754 Front Label 824754 Nicorette Original Gum 2 mg_200 ct.jpg
Principal Display Panel NDC 0135-0158-11 HALEON NICORETTE nicotine polacrilex gum, 4 mg stop smoking aid Gum 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. 200 PIECES, 4 mg EACH Original 824757 Front Label 824757 Nicorette Original Gum 4 mg_200 ct.jpg
Principal Display Panel NDC 0135-0466-02 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 2 mg 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 Gum COATED FOR BOLD FLAVOR 100 PIECES 2 mg EACH Cinnamon Surge 824735 Front Label 824735 Nicorette Cinnamon Surge 2 mg_100-new ct.jpg
Principal Display Panel NDC 0135-0467-02 HALEON NICORETTE nicotine polacrilex gum, 4 mg stop smoking aid Gum 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. COATED FOR BOLD FLAVOR 100 PIECES 4 mg EACH Cinnamon Surge 824738 Front Label 824738 Nicorette Cinnamon Surge 4 mg_100 ct-new.jpg
Principal Display Panel NDC 0135-0229-05 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 2 mg 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 Gum 170 PIECES, 2 mg EACH Mint 824762 Front Label 824762 Nicorette Mint 2 mg_170 ct.jpg
Principal Display Panel NDC 0135-0230-05 HALEON NICORETTE nicotine polacrilex gum, 4 mg stop smoking aid Gum 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 170 PIECES, 4 mg EACH Mint 824763 Front Label 824763 Nicorette Mint 4 mg_170 ct.jpg
Principal Display Panel NDC 0135-0532-02 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 2 mg 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 Gum COATED FOR BOLD FLAVOR 100 PIECES , 2 mg EACH Spearmint Burst with a hint of chamomile 824758 Front Label 824758 Nicorette Spearmint Burst 2 mg_100 ct.jpg
Principal Display Panel NDC 0135-0533-02 HALEON NICORETTE nicotine polacrilex gum, 2 mg stop smoking aid Gum 4 mg 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 2 mg Gum COATED FOR BOLD FLAVOR 100 PIECES , 4 mg EACH Spearmint Burst with a hint of chamomile 824760 Front Label 824760 Nicorette Spearmint Burst 4 mg_100 ct.jpg
Principal Display Panel NDC 0135-0355-03 HALEON NICORETTE nicotine polacrilex gum, 4 mg stop smoking aid Gum 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 COATED FOR BOLD FLAVOR 160 PIECES, 4 mg EACH Spearmint Burst with a hint of chamomile 824761 Front Label 824761 Nicorette Spearmint Burst 4 mg_160 ct
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.Other information (White Ice Mint) (2 mg) each piece contains: calcium 94 mg, sodium 11 mg (4 mg) each piece contains: calcium 94 mg, sodium 13 mg store at 20 - 25 o C (68 - 77 o F) protect from light
Other information (Original) each piece contains: calcium 117 mg, sodium 13 mg store at 20 - 25 o C (68 - 77 o F) protect from light
Other information (Cinnamon Surge) (2 mg) each piece contains: calcium 94 mg, sodium 11 mg (4 mg) each piece contains: calcium 94 mg, sodium 13 mg store at 20 - 25 o C (68 - 77 o F) protect from light
Other information (Mint) (2 mg) each piece contains: calcium 94 mg, sodium 13 mg (4 mg) each piece contains: calcium 94 mg, sodium 14 mg store at 20 - 25 o C (68 - 77 o F) protect from light
Other information (Spearmint Burst) (2 mg) each piece contains: calcium 94 mg, sodium 11 mg (4 mg) each piece contains: calcium 94 mg, sodium 13 mg store at 20 - 25 o C (68 - 77 o F) protect from light
Additional information found on packaging Includes Quit Support Program TO INCREASE YOUR SUCCESS IN QUITTING : You must be motivated to quit. Use Enough – Chew at least 9 pieces of Nicorette gum per day during the first six weeks. Use Long Enough – Use Nicorette gum for the full 12 weeks. Use with a support program as directed in the enclosed User’s Guide. To remove the gum, tear off single unit. Peel off backing, starting at corner with loose edge. Push gum through foil. 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 protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn. Nicorette is proud to offer a free individualized quit support program! Visit www.quit.com/join-myquit for details .
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 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 a 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.
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 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, 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 (For Cinnamon Surge) oral blistering occurs 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.
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. 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 a 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 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 (For Cinnamon Surge) oral blistering occurs you have symptoms of an allergic reaction (such as difficulty breathing or rash) 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.
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