Active Ingredient (In Each Patch)(Clear)
Nicotine, 21 mg delivered over 24 hours
Nicotine, 14 mg delivered over 24 hours
Nicotine, 7 mg delivered over 24 hours
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Nicoderm (NDC 0135-0195). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each patch)(clear), active ingredient (in each patch)(opaque), purpose, uses, if you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider., ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nicotine, 21 mg delivered over 24 hours
Nicotine, 14 mg delivered over 24 hours
Nicotine, 7 mg delivered over 24 hours
Nicotine, 21 mg delivered over 24 hours
Stop smoking aid
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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.
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.
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 |
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 |
ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings
ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between pigmented and clear polyester backings
call toll-free 1-800-834-5895 (English/Spanish) weekdays (9:00 a.m. - 4:30 p.m. ET)
NDC 0135-0194-02
NicoDerm®
CQ®
Nicotine Transdermal System 21 mg Delivered over 24 Hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE 24 HOURS
SMARTCONTROL® TECHNOLOGY
NEW DIRECTIONS FOR USE
- Keep Using if You Slip Up and Have a Cigarette
- Use Beyond 10 Weeks if Needed to Quit
STEP 1
IF YOU SMOKE MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1
10 OR LESS CIGARETTES A 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®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 16 or 24 hour period you wear the NicoDerm®CQ® patch. This helps to reduce cravings you may have for nicotine.
READ THE LABEL
NICODERM, NICODERM BURST DESIGN, CQ, COMMITTED QUITTERS, MAN ON STEP Device, SMARTCONTROL are trademarks 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.com or 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®CQ® patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.
Manufactured by ALZA Corporation,
Vacaville, CA 95688 for
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102839XB
NDC 0135-0195-02
NicoDerm®
CQ®
Nicotine Transdermal System 14 mg Delivered over 24 Hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE 24 HOURS
SMARTCONTROL® TECHNOLOGY
NEW DIRECTIONS FOR USE
- Keep Using if You Slip Up and Have a Cigarette
- Use Beyond 10 Weeks if Needed to Quit
STEP 2
IF YOU SMOKE 10 OR LESS CIGARETTES A DAY, START WITH STEP 2
MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1
ACTUAL SIZE
14 clear patches (2-week kit)
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 16 or 24 hour period you wear the NicoDerm®CQ® patch. This helps to reduce cravings you may have for nicotine.
READ THE LABEL
NICODERM, NICODERM BURST DESIGN, CQ, COMMITTED QUITTERS, MAN ON STEP Device, SMARTCONTROL are trademarks 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.com or 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®CQ® patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.
Manufactured by ALZA Corporation,
Vacaville, CA 95688 for
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102843XC
NDC 0135-0196-02
NicoDerm®
CQ®
Nicotine Transdermal System 7 mg Delivered over 24 Hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE 24 HOURS
SMARTCONTROL® TECHNOLOGY
NEW DIRECTIONS FOR USE
- Keep Using if You Slip Up and Have a Cigarette
- Use Beyond 10 Weeks if Needed to Quit
STEP 3
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®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 16 or 24 hour period you wear the NicoDerm®CQ® patch. This helps to reduce cravings you may have for nicotine.
READ THE LABEL
NICODERM, NICODERM BURST DESIGN, CQ, COMMITTED QUITTERS, MAN ON STEP Device, SMARTCONTROL are trademarks 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.com or 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®CQ® patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.
Manufactured by ALZA Corporation,
Vacaville, CA 95688 for
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102844XC
NDC 0135-0145-02
NicoDerm®
CQ®
Nicotine Transdermal System 21 mg Delivered over 24 Hours
STOP SMOKING AID
OPAQUE PATCH
EXTENDED RELEASE 24 HOURS
SMARTCONTROL® TECHNOLOGY
NEW DIRECTIONS FOR USE
- Keep Using if You Slip Up and Have a Cigarette
- Use Beyond 10 Weeks if Needed to Quit
STEP 1
IF YOU SMOKE MORE THAN 10 CIGARETTES A DAY, START WITH STEP 1
10 OR LESS CIGARETTES A 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®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 16 or 24 hour period you wear the NicoDerm®CQ® patch. This helps to reduce cravings you may have for nicotine.
READ THE LABEL
NICODERM, NICODERM BURST DESIGN, CQ, COMMITTED QUITTERS, MAN ON STEP Device, SMARTCONTROL are trademarks 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.com or 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®CQ® patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.
Manufactured by ALZA Corporation,
Vacaville, CA 95688 for
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
©2014 GSK
102838XB
* Please review the disclaimer below.