Label: NICODERM CQ- nicotine patch, extended release
-
NDC Code(s):
0135-0194-01,
0135-0194-02,
0135-0194-03,
0135-0194-05, view more0135-0194-08, 0135-0195-02, 0135-0195-03, 0135-0195-05, 0135-0195-08, 0135-0196-02, 0135-0196-05, 0135-0196-08
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 20, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each patch)
- Active ingredient (in each patch)
- Active ingredient (in each patch)
- Purpose
- Use
-
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)
-
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
- begin using the patch on your quit day
- 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
Weeks 7-8
Weeks 9-10
- if you smoke 10 or less cigarettes per day,do not use STEP 1 (21 mg).Start with STEP 2 (14 mg)for 6 weeks, then STEP 3 (7 mg)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
- it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
- Other information
- Inactive ingredients
- Questions or comments?
-
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
- 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.
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
-
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
- 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.
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
-
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
- 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.
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
-
INGREDIENTS AND APPEARANCE
NICODERM CQ
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0194 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 ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0194-01 7 in 1 CARTON 05/12/2011 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:0135-0194-02 14 in 1 CARTON 05/12/2011 2 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:0135-0194-03 1 in 1 PACKAGE 05/12/2011 3 21 in 1 CARTON 3 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 4 NDC:0135-0194-05 14 in 1 CARTON 05/12/2011 4 NDC:0135-0194-08 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 NDA020165 05/12/2011 NICODERM CQ
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0195 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 ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0195-02 14 in 1 CARTON 05/12/2011 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:0135-0195-03 1 in 1 PACKAGE 05/12/2011 2 21 in 1 CARTON 2 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:0135-0195-05 14 in 1 CARTON 05/12/2011 3 NDC:0135-0195-08 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 NDA020165 05/12/2011 NICODERM CQ
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0196 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 ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0196-02 14 in 1 CARTON 05/12/2011 1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:0135-0196-05 14 in 1 CARTON 05/12/2011 2 NDC:0135-0196-08 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 NDA020165 05/12/2011 Labeler - Haleon US Holdings LLC (079944263)
