Habitrol Patch Nicotine Transdermal System, Step 1

Dosage form: patch, extended release
Ingredients: NICOTINE 21mg in 24h
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-4870

Drug Facts

Active ingredient

Nicotine, 21mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

Use 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 another 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 have skin problems, because you are more likely to get rashes.

Ask a doctor or a 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
  • 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 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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

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 below:
  • if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
  • 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 the used patches 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
  • to avoid possible burns, remove patch  before  undergoing any MRI (magnetic resonance imaging) procedures
  • stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Comments or Questions?

Call 1-800-585-8682

Distributed by:

CVS Pharmacy

One CVS Drive

Woonsocket, RI 02895

Principal Display Panel

Step 1, 21 mg

HABITROL PATCH  NICOTINE TRANSDERMAL SYSTEM, STEP 1
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-4870
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE21 mg  in 24 h
Packaging
#Item CodePackage Description
1NDC:0067-4870-1414 POUCH (POUCH) in 1 CARTON
11 PATCH (PATCH) in 1 POUCH
124 h in 1 PATCH
2NDC:0067-4870-077 POUCH (POUCH) in 1 CARTON
21 PATCH (PATCH) in 1 POUCH
224 h in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02007602/26/2003
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 02/2010
 
Novartis Consumer Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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