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| Product NDC Code | 0135-0196 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nicoderm cq |
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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 | TRANSDERMAL | ||||||
| Dosage Form | PATCH, EXTENDED RELEASE | ||||||
| RxCUI drug identifier | 198029, 198030, 198031, 351427, 351429, 351433 |
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| Application Number | NDA020165 | ||||||
| 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 patch) Nicotine, 21 mg delivered over 24 hours
Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours
Active ingredient (in each patch) Nicotine, 7 mg delivered over 24 hours
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 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 information begin using the patch on your quit day if you smoke more than 10 cigarettes per day, use according to the following 10-week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10 if you smoke 10 or less cigarettes per day, do not use STEP 1 (21 mg). Start with STEP 2 (14 mg) for 6 weeks, then STEP 3 (7 mg) for 2 weeks and then stop. steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. remove backing from patch and immediately press onto skin. Hold for 10 seconds. wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User's Guide for safety and handling. you may wear the patch for 16 or 24 hours if you crave cigarettes when you wake up, wear the patch for 24 hours if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning the used patch should be removed and a new one applied to a different skin site at the same time each day do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment. If you feel you need to use the patch 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 ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings
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.NICODERM CQ nicotine ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) HIGH DENSITY POLYETHYLENE NICOTINE NICOTINE NICODERM CQ nicotine ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) HIGH DENSITY POLYETHYLENE NICOTINE NICOTINE NICODERM CQ nicotine ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) HIGH DENSITY POLYETHYLENE NICOTINE NICOTINE
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 0135-0194-02 NicoDerm CQ Nicotine Transdermal System 21 mg Delivered over 24 Hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS SMARTCONTROL TECHNOLOGY STEP 1 21 mg IF YOU SMOKE MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1 10 OR LESS CIGARETTES A DAY, START WITH STEP 2 ACTUAL SIZE 14 clear patches ( 2-week kit) What is the NicoDerm CQ Patch and How is it Used? NicoDerm CQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDerm CQ is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQ patch. This helps to reduce cravings you may have for nicotine. READ THE LABEL 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. Trademarks are owned by or licensed to the GSK group of companies. For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details. U.S. Patent No. 7,622,136 8,075,911 Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information. Includes Committed Quitters Program enrollment offer and User's Guide. TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Complete the full treatment program, applying a new patch every day. 3. Use with a support program as described in the enclosed User's Guide. For your family's protection, NicoDerm CQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Made in Ireland ©2021 GSK group of companies or its licensor. 1001595 PA1001595 Nicoderm CQ 21 mg clear patch 14 ct
Principal Display Panel NDC 0135-0195-02 NicoDerm CQ Nicotine Transdermal System 14 mg Delivered over 24 Hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS SMARTCONTROL TECHNOLOGY STEP 2 14 mg IF YOU SMOKE 10 OR LESS CIGARETTES A DAY, START WITH STEP 2 MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1 ACTUAL SIZE 14 clear patches ( 2-week kit) The full course of treatment for STEP 2 is 2 or 6 weeks (depending on how many cigarettes you smoke per day). Read the enclosed User’s Guide for additional information. What is the NicoDerm CQ Patch and How is it Used? NicoDerm CQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDerm CQ is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQ patch. This helps to reduce cravings you may have for nicotine. READ THE LABEL 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. Trademarks are owned by or licensed to the GSK group of companies. For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details. U.S. Patent No. 7,622,136 8,075,911 Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information Includes Committed Quitters Program enrollment offer and User's Guide. TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Complete the full treatment program, applying a new patch every day. 3. Use with a support program as described in the enclosed User's Guide. For your family's protection, NicoDerm CQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Made in Ireland ©2022 GSK group of companies or its licensor. PA201227 PA201227 Nicoderm CQ 14 mg clear patch 14 count
Principal Display Panel NDC 0135-0196-02 NicoDerm CQ Nicotine Transdermal System 7 mg Delivered over 24 Hours STOP SMOKING AID CLEAR PATCH EXTENDED RELEASE 24 HOURS SMARTCONTROL TECHNOLOGY STEP 3 7 mg FOR USE AFTER COMPLETING STEP 2 ACTUAL SIZE 14 clear patches ( 2-week kit) What is the NicoDerm CQ Patch and How is it Used? NicoDerm CQ is a small, nicotine-containing patch. When you put on a NicoDerm CQ patch, nicotine passes through the skin and into your body. NicoDerm CQ is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQ patch. This helps to reduce cravings you may have for nicotine. READ THE LABEL 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. Trademarks are owned by or licensed to the GSK group of companies. For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.com or see inside for more details. U.S. Patent No. 7,622,136 8,075,911 Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information Includes Committed Quitters Program enrollment offer and User's Guide. TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Complete the full treatment program, applying a new patch every day. 3. Use with a support program as described in the enclosed User's Guide. For your family's protection, NicoDerm CQ patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Made in Ireland ©2022 GSK group of companies or its licensor. PA200699 PA200699 Nicoderm CQ 7 mg clear patch 14 ct 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 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. an allergy to adhesive tape or have skin problems because you are more likely to get rashes stomach ulcers 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 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. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
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 1-800-834-5895
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 skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime
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 store at 20-25°C (68-77°F)
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 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. an allergy to adhesive tape or have skin problems because you are more likely to get rashes stomach ulcers or diabetes history of seizures 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. When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, 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. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
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