NICOTINE  TRANSDERMAL SYSTEM- nicotine patch, extended release 
Sam's West Inc

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Drug Facts

Active ingredient (in each patch)

Nicotine, 21 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.

Do Not Use

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum 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 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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Directions

  1. STEP 1
  1. STEP 2
  1. STEP 3
  1. Use one 21 mg patch/day
  1. Use one 14 mg patch/day
  1. Use one 7 mg patch/day
  1. Weeks 1-6
  1. Weeks 7-8
  1. Weeks 9-10

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Questions or comments?

call toll-free 1-866-255-5205(English/Spanish) weekdays

TO INCREASE YOUR SUCCESS IN QUITTING:

Principal Display Panel

NDC 68196-194-03

nicotine patch

Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

21 mg

SIMPLY RIGHT

Health Care

Compare to NicoDerm ®CQ ®*

Includes behavior support program enrollment form & user’s guide

If you smoke more than 10 cigarettes per day: start with step 1

If you smoke 10 or lesscigarettes per day: start with step 2

step 1

21 clear patches

©2011

101775XA

101775XA Nicotine Patch Sams 21 mg 21 ct carton
NICOTINE   TRANSDERMAL SYSTEM
nicotine patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-194
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
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-194-0321 in 1 CARTON03/02/2012
124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02016503/02/2012
Labeler - Sam's West Inc (051957769)
Registrant - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 142cbdf8-1278-c788-e063-6394a90ac06d
Set id: cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7
Version: 9
Effective Time: 20240321
 
Sam's West Inc