SPL v2
SPL
SPL Set ID 9265d2b3-1f87-45ea-ba0a-5192175b4309
Route
TRANSDERMAL
Published
Effective Date 2011-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Dimethicone

Identifiers & Packaging

Marketing Status
ANDA Active Since 1997-10-20

Description

Drug Facts

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Drug Facts

Uses

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 42229-5

Drug Facts

Section 51945-4
Section 53414-9

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. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Directions
  • 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:
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 smoke 10 or start with for 6 weeks, then for 2 weeks and then stop less cigarettes per day, Step 2 Step 3
  • Apply one new patch every 24 hours on skin that is dry, clean, and hairless
  • Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
  • Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.
  • The used patch should be removed and a new one applied to a different skin site at the same time each day
  • If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
  • 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
  • Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.
Do Not Use
  • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products
Other Information

Store at 20°-25°C (68°-77°F)

Inactive Ingredients

acrylate adhesive, polyester, silicone adhesive

Comments Or Questions?

Call-1-877-440-7867 8 AM - 8PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

When Using This Product
  • Do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
  • 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
Active Ingredient (in Each Patch)

Nicotine, 21 mg delivered over 24 hours

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
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.

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.

Structured Label Content

Uses

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

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. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Purpose

Stop smoking aid

Directions
  • 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:
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 smoke 10 or start with for 6 weeks, then for 2 weeks and then stop less cigarettes per day, Step 2 Step 3
  • Apply one new patch every 24 hours on skin that is dry, clean, and hairless
  • Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
  • Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.
  • The used patch should be removed and a new one applied to a different skin site at the same time each day
  • If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
  • 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
  • Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.
Do Not Use (Do not use)
  • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products
Other Information (Other information)

Store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

acrylate adhesive, polyester, silicone adhesive

Comments Or Questions? (Comments or questions?)

Call-1-877-440-7867 8 AM - 8PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

When Using This Product (When using this product)
  • Do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
  • If you have vivid dreams or other sleep disturbances, remove this patch at bedtime
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Patch) (Active ingredient (in each patch))

Nicotine, 21 mg delivered over 24 hours

Ask A Doctor Before Use If You Have (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
Keep Out of Reach of Children and Pets (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.

Ask A Doctor Or Pharmacist Before Use If You Are (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.

Advanced Ingredient Data


Raw Label Data

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