Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release
- NDC Code(s): 68196-194-03
- Packager: Sam's West Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
If you are a consumer or patient please visit this version.
- Active ingredient (in each patch)
Nicotine, 21 mg delivered over 24 hoursClose
Stop smoking aidClose
reduces withdrawal symptoms, including nicotine craving, associated with quitting smokingClose
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.
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.
- 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 7mg patch/day
- Weeks 1-6
- Weeks 7-8
- Weeks 9-10
- Other information
store at 20-25°C (68-77°F)Close
- Inactive ingredients
ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backingsClose
- 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 GUARENTEED 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
- Principal Display Panel
Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid
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
21 clear patches
- INGREDIENTS AND APPEARANCE
NICOTINE TRANSDERMAL SYSTEM
nicotine patch, extended release
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68196-194 Route of Administration TRANSDERMAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 21 mg in 24 h Inactive Ingredients Ingredient Name Strength ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) HIGH DENSITY POLYETHYLENE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-194-03 21 in 1 CARTON 1 24 h in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020165 03/02/2012 Labeler - Sam's West Inc (051957769) Registrant - sanofi-aventis U.S. LLC (011330557)