NICOTINE TRANSDERMAL SYSTEM- nicotine transdermal system 
Rite Aid Corporation

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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.

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.

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-56 count CARTON

Nicotine Transdermal System

NDC No. 11822-1603-1

56 Patches

56 count CTN.jpg

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1603
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1603-11 in 1 CARTON; Type 1: Convenience Kit of Co-Package09/15/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 128 POUCH 28 
Part 214 POUCH 14 
Part 314 POUCH 14 
Part 1 of 3
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Item Code (Source)NDC:11822-1602
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1602-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461209/15/2021
Part 2 of 3
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Item Code (Source)NDC:11822-1601
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1601-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461209/15/2021
Part 3 of 3
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Item Code (Source)NDC:11822-1600
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1600-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461209/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461209/15/2021
Labeler - Rite Aid Corporation (014578892)
Registrant - Aveva Drug Delivery Systems (783982093)
Establishment
NameAddressID/FEIBusiness Operations
Aveva Drug Delivery Systems Inc.783982093analysis(11822-1600, 11822-1601, 11822-1602, 11822-1603) , manufacture(11822-1600, 11822-1601, 11822-1602, 11822-1603)

Revised: 7/2023
Document Id: 005c2190-a0bb-1581-e063-6394a90a2e1b
Set id: a2df73b3-8c06-85fb-c94b-ca8fcd546987
Version: 3
Effective Time: 20230713
 
Rite Aid Corporation