Other
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Ingenus Pharmaceuticals, Llc for the product Nicotine Transdermal System (NDC 50742-668). 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 other, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
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 1-800-222-1222 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 |
store at 20°C-25°C (68°F-77°F)
acrylate adhesive, polyester, silicone adhesive
1-877-748-1970
1. You must be motivated to quit.
2. Use one patch daily according to directions.
3. It is important to complete treatment.
4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
5. Use patch with a behavioral support program, such as the one described in the enclosed booklet.
ingenus
NDC 50742-670-07
*COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*
Clear
Nicotine
Transdermal System Patch
21 mg
21 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
STEP ONE
If you smoke
MOREthan 10 cigarettes per day: Start with Step 1
If you smoke 10 or
LESScigarettes per day: Start with Step 2
7 PATCHES
*Habitrol ®is a registered trademark of Dr. Reddy's Laboratories Ltd.
ingenus
NDC 50742-669-07
*COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*
Clear
Nicotine
Transdermal System Patch
14 mg
14 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
STEP TWO
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.
7 PATCHES
*Habitrol ®is a registered trademark of Dr. Reddy's Laboratories Ltd.
ingenus
NDC 50742-668-07
*COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*
Clear
Nicotine
Transdermal System Patch
7 mg
7 mg delivered over 24 hours
STOP SMOKING AID
Includes Behavior Support Program with Self-Help Guide
STEP THREE
For use after completing Step 2
7 PATCHES
*Habitrol ®is a registered trademark of Dr. Reddy's Laboratories Ltd.
* Please review the disclaimer below.