NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release

NICOTINE by

Drug Labeling and Warnings

NICOTINE by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Step 1 (in each patch)

Nicotine, 21mg delivered over 24 hours

Active ingredient Step 2 (in each patch)

Nicotine, 14mg delivered over 24 hours

Active ingredient Step 3 (in each patch)

Nicotine, 7mg 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 21mg patch/day	Use one 14mg patch/day	Use one 7mg 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.

Other information

store at 20 – 25oC (68 – 77oF)

Inactive ingredients

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

Questions or comments?

call toll-free 1-888-287-1915

For your family's protection, nicotine patches are supplied in child-resistant pouches.

Do not use if individual pouch/packet is damaged or open.

Walmart

If this product is found for sale at a location other than Walmart please call 1-800-WAL-MART.

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.

• 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.

Free audio CD upon request. See inside.

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Made in Switzerland

Distributed by:

Wal-Mart Stores, Inc.,

Bentonville, AR 72716

© Wal-Mart Stores, Inc.

*NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.

What is the nicotine patch and how is it used?

The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The 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

READ THE LABEL

PRINCIPAL DISPLAY PANEL

NDC: 49035-194-02

Clear

Nicotine

Transdermal

System

equate®

Compare to NicoDerm® CQ®*

21mg Delivered Over 24 hours

Stop Smoking Aid

Includes User's Guide with behavior support program enrollment form

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

14 PATCHES

STEP 1

100224XA

PRINCIPAL DISPLAY PANEL

 NDC: 49035-195-02

Clear

Nicotine

Transdermal

System

equate®

Compare to NicoDerm® CQ®*

14mg Delivered Over 24 hours

Stop Smoking Aid

Includes User's Guide with behavior support program enrollment form

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

14 mg

14 PATCHES

STEP 2

100222XA

PRINCIPAL DISPLAY PANEL

 NDC: 49035-196-02

Clear

Nicotine

Transdermal

System

equate®

Compare to NicoDerm® CQ®*

7mg Delivered Over 24 hours

Stop Smoking Aid

Includes User's Guide

For use after completing Step 2

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

7 mg

14 PATCHES

STEP 3

100352XA

INGREDIENTS AND APPEARANCE

NICOTINE  TRANSDERMAL SYSTEM
nicotine patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-194
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	21 mg  in 24 h

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-194-02	14 in 1 CARTON	10/19/2010
1		24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 49035-194-01	7 in 1 CARTON	10/19/2010
2		24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020165	10/19/2010

NICOTINE  TRANSDERMAL SYSTEM
nicotine patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-195
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	14 mg  in 24 h

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-195-02	14 in 1 CARTON	10/19/2010
1		24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020165	10/19/2010

NICOTINE  TRANSDERMAL SYSTEM
nicotine patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-196
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	7 mg  in 24 h

Inactive Ingredients
Ingredient Name	Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-196-02	14 in 1 CARTON	10/19/2010
1		24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020165	10/19/2010

Labeler - Wal-Mart Stores Inc (051957769)