Nicotine Transdermal System
Drug Facts
Active ingredient Step One (in each patch)
Nicotine, 21 mg delivered over 24 hours
Active ingredient Step Two (in each patch)
Nicotine, 14 mg delivered over 24 hours
Active ingredient Step Three (in each patch)
Nicotine, 7 mg delivered over 24 hours
Purpose
Stop smoking aid
Uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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.
Do not use
- If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products
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 skin problems because you are more likely to get rashes.
- stomach ulcer 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 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)
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. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.
Directions
| 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 |
- If you are under 18 years of age, ask a doctor before use
- Before using this product, read the enclosed self-help 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 the following schedule:
Other information
Store at 20°-25°C (68°-77°F)
Inactive ingredients
acrylate adhesive, polyester, silicone adhesive
TO INCREASE YOUR SUCCESS IN QUITTING:
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.
For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.
- Not for sale to persons 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.
HOW SUPPLIED
Product: 50090-1148
NDC: 50090-1148-0 1 h in a POUCH / 14 in a CARTON
Product: 50090-1694
NDC: 50090-1694-0 1 h in a POUCH / 14 in a CARTON
Product: 50090-1697
NDC: 50090-1697-0 1 h in a POUCH / 14 in a CARTON