FDA Label for Nicoderm CQ
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- DIRECTIONS (CLEAR)
- DIRECTIONS (OPAQUE)
- OTHER INFORMATION
- INACTIVE INGREDIENTS (CLEAR)
- INACTIVE INGREDIENTS (OPAQUE)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Nicoderm CQ Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Active Ingredient (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
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
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
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 (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• 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:• 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.
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 |
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:• 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• 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• 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.
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
• 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
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
• 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.• 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.• 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.• 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, 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.