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| Product NDC Code | 68196-194 | ||||
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| Drug Name | Nicotine transdermal system |
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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 | 198030 | ||||
| Application Number | NDA020165 | ||||
| Labeler Name | Sam's West 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 patch) Nicotine, 21 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 stop smoking completely when you begin using the patch 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 (21mg). Start with STEP 2 (14mg) , for 6 weeks, then STEP 3 (7mg) 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 stop using the patch at the end of 10 weeks. If you started with STEP 2 , stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.
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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.Nicotine transdermal system 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 68196-194-03 nicotine patch Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid 21 mg SIMPLY RIGHT ™ Health Care Compare to NicoDerm ® CQ ® * Includes behavior support program enrollment form & user’s guide If you smoke more than 10 cigarettes per day: start with step 1 If you smoke 10 or less cigarettes per day: start with step 2 step 1 21 clear patches ©2011 101775XA 101775XA Nicotine Patch Sams 21 mg 21 ct carton
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 store at 20-25°C (68-77°F)
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.
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. When using this product do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. if you have vivid dreams or other sleep disturbances remove this patch at bedtime
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 if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products
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 1-866-255-5205 (English/Spanish) weekdays TO INCREASE YOUR SUCCESS IN QUITTING: You must be motivated to quit. Complete the full treatment program, applying a new patch every day. Use with a support program as described in the enclosed User’s Guide. For your family’s protection, Nicotine Patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open. Nicotine transdermal system 21 mg delivered over 24 hours Stop smoking aid Not for sale to those under 18 years of age. Prrof of age required. Not for sale in vending machines or from any source where proof of age cannot be verified. Free Audio CD upon request. See inside. What is the Nicotine Patch and How is it Used? Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch, nicotine passes through the skin and into your body. Nicotine Patch 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 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine. Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information. THE SIMPLY RIGHT™ PROMISE Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations. We would like to hear from you with any comments or suggestions. In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at samsclub.com. Distributed by: SAM’S West, Inc. Bentonville, AR 72716 *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in Switzerland Send comments/questions to: GCSP 5.4376.4C Consumer Relations P.O. Box 13398 Research Triangle Park, NC 27709-9627
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
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 do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. 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.
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 if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products 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. 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 do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. 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 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