NICODERM  CQ- nicotine patch, extended release 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each patch)

Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch)

Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch)

Nicotine, 7 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.

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
  • stomach ulcers or diabetes
  • history of seizures

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

  • 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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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

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

Other information

Inactive ingredients

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

Questions or comments?

call toll-free 1-800-834-5895

Principal Display Panel

NDC 0135-0194-02

NicoDermCQ

Nicotine Transdermal System 21 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 1

21 mg

IF YOU SMOKE MORE THAN 10 CIGARETTESA DAY, START WITH STEP 1

10 OR LESS CIGARETTESA DAY, START WITH STEP 2

ACTUAL SIZE

14 clear patches( 2-week kit)

What is the NicoDerm CQ Patch and How is it Used?

NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis 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 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

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

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

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 CQpatches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Made in Ireland

©2021 GSK group of companies or its licensor.

1001595

PA1001595 Nicoderm CQ 21 mg clear patch 14 ct

Principal Display Panel

NDC 0135-0195-02

NicoDermCQ

Nicotine Transdermal System 14 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 2

14 mg

IF YOU SMOKE 10 OR LESS CIGARETTESA DAY, START WITH STEP 2

MORE THAN 10 CIGARETTESA DAY, START WITH STEP 1

ACTUAL SIZE

14 clear patches( 2-week kit)

The full course of treatment for STEP 2 is 2 or 6 weeks (depending on how many cigarettes you smoke per day). Read the enclosed User’s Guide for additional information.

What is the NicoDerm CQ Patch and How is it Used?

NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis 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 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

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

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

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 CQpatches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Made in Ireland

©2022 GSK group of companies or its licensor.

PA201227

PA201227 Nicoderm CQ 14 mg clear patch 14 count

Principal Display Panel

NDC 0135-0196-02

NicoDermCQ

Nicotine Transdermal System 7 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 3

7 mg

FOR USE AFTER COMPLETING STEP 2

ACTUAL SIZE

14 clear patches( 2-week kit)

What is the NicoDerm CQ Patch and How is it Used?

NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis 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 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

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

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

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 CQpatches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Made in Ireland

©2022 GSK group of companies or its licensor.

PA200699

PA200699 Nicoderm CQ 7 mg clear patch 14 ct carton
NICODERM   CQ
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0194
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0194-017 in 1 CARTON05/12/2011
124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0135-0194-0214 in 1 CARTON05/12/2011
224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0135-0194-031 in 1 PACKAGE05/12/2011
321 in 1 CARTON
324 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:0135-0194-0514 in 1 CARTON05/12/2011
4NDC:0135-0194-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016505/12/2011
NICODERM   CQ
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0195
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0195-0214 in 1 CARTON05/12/2011
124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0135-0195-031 in 1 PACKAGE05/12/2011
221 in 1 CARTON
224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0135-0195-0514 in 1 CARTON05/12/2011
3NDC:0135-0195-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016505/12/2011
NICODERM   CQ
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0196
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0196-0214 in 1 CARTON05/12/2011
124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0135-0196-0514 in 1 CARTON05/12/2011
2NDC:0135-0196-0824 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016505/12/2011
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 14191fd7-ca49-9fbc-e063-6394a90afd9a
Set id: 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef
Version: 12
Effective Time: 20240320
 
Haleon US Holdings LLC