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Name:Nicodermcq
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NICODERM CQ - nicotine patch, extended release 
GlaxoSmithKline Consumer Healthcare LP

----------

Drug Facts

Active ingredient (in each patch)(clear)

Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch)(clear)

Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch)(clear)

Nicotine, 7 mg delivered over 24 hours

Active ingrdient (in each patch)(opaque)

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

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

  • don 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 Posion Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Directions (Clear)

  • 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 Week 7-8 Week 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.

Directions (Opaque)

  • 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 follow 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 Week 7-8 Week 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
  • to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
  • 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 20-25°C (68-77°F)

Inactive ingredients (Clear)

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

Inactive ingredients (Opaque)

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

Questions or comments?

call toll-free 1-800-834-5895 (English/Spanish) weekdays (9:00 a.m. - 4:30 p.m. ET)

Principal Display Panel

NICODERM®

CQ®

CLEAR

with patented SmartControl® Technology

NICOTINE TRANSDERMAL SYSTEM

21 MG DELIVERED OVER 24 HOURS

STOP SMOKING AID

If You Smoke:

  • more than 10 cigarettes per day: start with step 1
    • 10 or less cigarettes per day: start with step 2

STEP 1

14 Clear Patches

2-Week Kit

 NicoDerm® CQ® is a three step program. You start with the highest level of medicine and gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

For more information, please visit www.nicodermcq.com

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 24 or 16 hour period you wear the NicoDerm® CQ® patch. This helps to reduce cravings you may have for nicotine.

  • 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.

NICODERM®, CQ®, SMARTCONTROL®, COMMITTED QUITTERS™, INDIVIDUALIZED STOP SMOKING PROGRAM COMMITTED QUITTERS Design, Shield Trade Dress/Designs and Man on Steps Design are trademarks owned by and/or licensed to the GlaxoSmithKline 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. 5,508,038

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.
Free Audio CD upon request.

See inside.

Includes Committed Quitters™ Program enrollment offer and User's Guide.

Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

Manufactured by ALZA Corporation,

Vacaville, CA 95688 for

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

©2010 GlaxoSmithKline

100039XA

NicoDerm CQ 21 mg carton

Principal Display Panel

NICODERM®

CQ®

CLEAR

with patented SmartControl® Technology

NICOTINE TRANSDERMAL SYSTEM

14 MG DELIVERED OVER 24 HOURS

STOP SMOKING AID

If You Smoke:

  • more than 10 cigarettes per day: start with step 1
    • 10 or less cigarettes per day: start with step 2

STEP 2

14 Clear Patches

2-Week Kit

 NicoDerm® CQ® is a three step program. You start with the highest level of medicine and gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

For more information, please visit www.nicodermcq.com

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 24 or 16 hour period you wear the NicoDerm® CQ® patch. This helps to reduce cravings you may have for nicotine.

  • 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.

NICODERM®, CQ®, SMARTCONTROL®, COMMITTED QUITTERS™, INDIVIDUALIZED STOP SMOKING PROGRAM COMMITTED QUITTERS Design, Shield Trade Dress/Designs and Man on Steps Design are trademarks owned by and/or licensed to the GlaxoSmithKline 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. 5,508,038

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.
Free Audio CD upon request.

See inside.

Includes Committed Quitters™ Program enrollment offer and User's Guide.

Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

Manufactured by ALZA Corporation,

Vacaville, CA 95688 for

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

©2010 GlaxoSmithKline

100038XA

NicoDerm CQ 14 mg carton

Principal Display Panel

NICODERM®

CQ®

CLEAR

with patented SmartControl® Technology

NICOTINE TRANSDERMAL SYSTEM

7 MG DELIVERED OVER 24 HOURS

STOP SMOKING AID

For use after completing Step 2

STEP 3

14 Clear Patches

2-Week Kit

 NicoDerm® CQ® is a three step program. You start with the highest level of medicine and gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

For more information, please visit www.nicodermcq.com

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 24 or 16 hour period you wear the NicoDerm® CQ® patch. This helps to reduce cravings you may have for nicotine.

  • 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.

NICODERM®, CQ®, SMARTCONTROL®, COMMITTED QUITTERS™, INDIVIDUALIZED STOP SMOKING PROGRAM COMMITTED QUITTERS Design, Shield Trade Dress/Designs and Man on Steps Design are trademarks owned by and/or licensed to the GlaxoSmithKline 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. 5,508,038

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.
Free Audio CD upon request.

See inside.

Includes Committed Quitters™ Program enrollment offer and User's Guide.

Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

Manufactured by ALZA Corporation,

Vacaville, CA 95688 for

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

©2010 GlaxoSmithKline

100079XA

NicoDerm CQ 7 mg carton

Principal Display Panel

NICODERM®

CQ®

OPAQUE

with patented SmartControl® Technology

NICOTINE TRANSDERMAL SYSTEM

21 MG DELIVERED OVER 24 HOURS

STOP SMOKING AID

If You Smoke:

  • more than 10 cigarettes per day: start with step 1
    • 10 or less cigarettes per day: start with step 2

STEP 1

14 Opaque Patches

2-Week Kit

 NicoDerm® CQ® is a three step program. You start with the highest level of medicine and gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

For more information, please visit www.nicodermcq.com

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 24 or 16 hour period you wear the NicoDerm® CQ® patch. This helps to reduce cravings you may have for nicotine.

  • 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.

NICODERM®, CQ®, SMARTCONTROL®, COMMITTED QUITTERS™, INDIVIDUALIZED STOP SMOKING PROGRAM COMMITTED QUITTERS Design, Shield Trade Dress/Designs and Man on Steps Design are trademarks owned by and/or licensed to the GlaxoSmithKline 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. 5,508,038

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.
Free Audio CD upon request.

See inside.

Includes Committed Quitters™ Program enrollment offer and User's Guide.

Read carton and enclosed User's Guide before using this product. Keep this carton and User's Guide. They contain important information

Manufactured by ALZA Corporation,

Vacaville, CA 95688 for

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Switzerland

©2010 GlaxoSmithKline

100082XA

NicoDerm CQ 21 mg Opaque carton


NICODERM  CQ
nicotine patch, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0194
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0194-01 7 PATCH ( PATCH) in 1 CARTON contains a PATCH
1 24 h in 1 PATCH This package is contained within the CARTON (0135-0194-01)
2 NDC:0135-0194-02 14 PATCH ( PATCH) in 1 CARTON contains a PATCH
2 24 h in 1 PATCH This package is contained within the CARTON (0135-0194-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 05/12/2011

NICODERM  CQ
nicotine patch, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0195
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 14 mg  in 24 h
Inactive Ingredients
Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
HIGH DENSITY POLYETHYLENE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0195-02 14 PATCH ( PATCH) in 1 CARTON contains a PATCH
1 24 h in 1 PATCH This package is contained within the CARTON (0135-0195-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 05/12/2011

NICODERM  CQ
nicotine patch, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0196
Route of Administration TRANSDERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 7 mg  in 24 h
Inactive Ingredients
Ingredient Name Strength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
HIGH DENSITY POLYETHYLENE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0196-02 14 PATCH ( PATCH) in 1 CARTON contains a PATCH
1 24 h in 1 PATCH This package is contained within the CARTON (0135-0196-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 05/12/2011

NICODERM  CQ
nicotine patch, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0145
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  
Product Characteristics
Color WHITE (Opaque) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0145-02 14 PATCH ( PATCH) in 1 CARTON contains a PATCH
1 24 h in 1 PATCH This package is contained within the CARTON (0135-0145-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020165 05/12/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 05/2011 GlaxoSmithKline Consumer Healthcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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