NICOTINE TRANSDERMAL SYSTEM- nicotine transdermal system patch, extended release 
Walgreens

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Nicotine Transdermal System- nicotine patch, extended release

Drug Fact

Active ingredient(in each patch)  

Step 1 - Nicotine, 21 mg delivered over 24 hours

Step 2 - Nicotine, 14 mg delivered over 24 hours

Step 3 - Nicotine, 7 mg delivered over 24 hours

Purpose

Stop smoking aid

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.

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.
  • 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 the 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.
  • 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 the used patches by folding sticky ends together and putting in pouch.

Directions

Other information  

store at 20 °C – 25 °C (68 °F – 77 °F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Comments or Questions?

1-844-562-7963

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

Nicotine Transdermal System

NDC No. 0363-1244-01

14 Patches

14mgcarton.jpg

PRINCIPAL DISPLAY PANEL - 7 mg CARTON

Nicotine Transdermal System

NDC No. 0363-1243-01

14 Patches

7mgcarton.jpg

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

Nicotine Transdermal System

NDC No. 0363-1245-01

14 Patches

21mgcarton.jpg

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1244
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1244-0114 in 1 CARTON04/01/2019
11 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461204/01/2019
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1243
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1243-0114 in 1 CARTON04/01/2019
11 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461204/01/2019
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1245
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1245-0114 in 1 CARTON04/01/2019
11 h in 1 POUCH; Type 0: Not a Combination Product
2NDC:0363-1245-027 in 1 CARTON04/01/2019
21 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461204/01/2019
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Aveva Drug Delivery Systems Inc.783982093manufacture(0363-1243, 0363-1244, 0363-1245) , analysis(0363-1243, 0363-1244, 0363-1245)

Revised: 7/2023
Document Id: 005c2190-a0cd-1581-e063-6394a90a2e1b
Set id: 5aadb95f-428c-b637-01f4-50d5866ced0c
Version: 5
Effective Time: 20230713
 
Walgreens