NICOTINE- nicotine patch 
TYA Pharmaceuticals

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Drug Facts

Active ingredient (in each patch)

Nicotine, 14 mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

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. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Do not use

  • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use 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 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 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 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 used patch by folding sticky ends together and putting in pouch.

Directions

Weeks 1 thru 4Weeks 5 and 6Weeks 7 and 8
STEP 1STEP 2STEP 3
use one 21 mg patch/dayuse one 14 mg patch/dayuse one 7 mg patch/day

Other information

  • Store at 20°-25°C (68°-77°F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Comments or questions?

Call-1-877-440-7867 8 AM - 8PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

Label Image
NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-5895(NDC:0536-5895)
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:64725-5895-114 h in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461210/20/1997
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-5895) , REPACK(64725-5895)

Revised: 8/2011
Document Id: 0f3e08a2-667b-48cf-b9ce-2ca878a74081
Set id: f00d85f4-2b4f-4281-b72e-9de730140e41
Version: 2
Effective Time: 20110823
 
TYA Pharmaceuticals