Active Ingredient (In Each Patch)
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 Aveva Drug Delivery Systems, Inc. for the product Nicotine Transdermal System (NDC 3215-0121). 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), purpose, use, otc - pregnancy or breast feeding, 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, 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
Stop smoking aid
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.
Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
| Weeks 1 thru 4 | Weeks 5 and 6 | Weeks 7 and 8 |
| Step 1 | Step 2 | Step 3 |
| use one 21 mg patch/day | use one 14 mg patch/day | use one 7 mg patch/day |
acrylate adhesive, polyester, silicone adhesive
1-888-889-8893
NDC 3215-0122-14
Nicotine
Nicotine Transdermal System 21 mg delivered over 24 hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE
24 HOURS
Includes Behavior Support Program with Self-help Guide
If you smoke MOREthan 10 cigarettes per day: Start with Step 1.
If you smoke 10 or LESScigarettes per day: Start with Step 2.
STEP 1
21 mg
14 clear patches (2 week kit)
COMPARE TO HABITROL ®
active ingredient*
NDC 3215-0121-14
Nicotine
Nicotine Transdermal System 14 mg delivered over 24 hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE
24 HOURS
Includes Behavior Support Program with Self-help Guide
If you smoke
MOREthan 10 cigarettes per day:
Use after completing Step 1.
If you smoke 10 or
LESScigarettes per day:
Start with Step 2.
STEP 2
14 mg
14 clear patches
(2 week kit)
COMPARE TO HABITROL ®
active ingredient*
NDC 3215-0120-14
Nicotine
Nicotine Transdermal System 7 mg delivered over 24 hours
STOP SMOKING AID
CLEAR PATCH
EXTENDED RELEASE
24 HOURS
Includes Behavior Support Program with Self-help Guide
For use after completing step 2
STEP 3
7 mg
14 clear patches
(2 week kit)
COMPARE TO HABITROL ®
active ingredient*
* Please review the disclaimer below.