Your browser does not support JavaScript! NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]
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NICOTINE TRANSDERMAL SYSTEM (nicotine) patch, extended release
[Sam's West Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Active ingredient (in each patch)

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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.

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 7mg patch/day
 
Weeks 1-6
 
Weeks 7-8
 
Weeks 9-10

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Questions or comments?

call toll-free 1-866-255-5205 (English/Spanish) weekdays

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, 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

NDC 68196-194-03

nicotine patch

Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

Compare to NicoDerm®CQ®*

SIMPLY RIGHT

Health Care

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 mg

step 1

21 clear patches

©2011

101775XA

101775XA Nicotine Patch Sams 21 mg 21 ct carton
NICOTINE  TRANSDERMAL SYSTEM
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68196-194
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) 
HIGH DENSITY POLYETHYLENE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-194-0321 in 1 CARTON
124 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016503/02/2012
Labeler - Sam's West Inc (051957769)
Registrant - sanofi-aventis U.S. LLC (011330557)

Revised: 11/2013
 
Sam's West Inc

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