MEDLINE- nicotine patch 
Medline Industries, LP

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191/2/3 Nicotine Transdermal Patch

Active ingredient (in each patch)

Purpose

Stop smoking aid

Use

Warnings

Ask 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, or 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

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Questions or comments?

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.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive

Northfield, IL 60093 USA

Manufactured by:

Apotex Corp.

2400 N Commerce Pkwy

Weston, FL 33326

Made in USA of Foreign and Domestic Materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM019285; OTCM019189; OTCM019389

V3 RI22AOE

Package Labels

Label 191 V3 RI22AOE

Label 192 V3 RI22AOE

Label 193 V3 RI22AOE

MEDLINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-193
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-193-8914 in 1 CARTON08/28/2022
1NDC:53329-193-091 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07464506/30/2022
MEDLINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-192
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:53329-192-8914 in 1 CARTON08/28/2022
1NDC:53329-192-091 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461206/30/2022
MEDLINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-191
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:53329-191-8914 in 1 CARTON08/28/2022
1NDC:53329-191-091 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461106/30/2022
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 7/2023
Document Id: 017eb760-49ef-5ff6-e063-6294a90a6268
Set id: e11a4b7e-6f1f-24db-e053-2a95a90a0d09
Version: 5
Effective Time: 20230727
 
Medline Industries, LP