Label: NICOTINE TRANSDERMAL SYSTEM patch, extended release
- NDC Code(s): 60505-7064-0, 60505-7065-0, 60505-7066-0
- Packager: Apotex Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Fact
- Active ingredient(in each patch)
- Purpose
- Use
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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.
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 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 blood stream 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.
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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
- begin using the patch on your quit day
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if yousmoke
more than 10 cigarettes per day,use the following schedule below:
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 less cigarettes per day,start with Step 2for 6 weeks, then Step 3for 2 weeks
- 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
- it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
- Other information
- Inactive ingredients
- Comments or Questions?
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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.
- PRINCIPAL DISPLAY PANEL - 14 mg CARTON
- PRINCIPAL DISPLAY PANEL - 7 mg CARTON
- PRINCIPAL DISPLAY PANEL- 21 mg CARTON
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INGREDIENTS AND APPEARANCE
NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7065 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 14 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60505-7065-0 14 in 1 CARTON 10/20/1997 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7064 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 7 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60505-7064-0 14 in 1 CARTON 10/20/1997 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7066 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 21 mg in 24 h Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60505-7066-0 14 in 1 CARTON 10/20/1997 1 1 h in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 Labeler - Apotex Corp (845263701) Registrant - Aveva Drug Delivery Systems (783982093) Establishment Name Address ID/FEI Business Operations Aveva Drug Delivery Systems 783982093 analysis(60505-7065, 60505-7064, 60505-7066) , manufacture(60505-7065, 60505-7064, 60505-7066)
