NICOTINE- nicotine polacrilex lozenge 
Cardinal Health (Leader) 70000

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex USP,  2 mg


Purpose

Stop smoking aid

Use

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

  • a sodium-restricted diet
  • 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.
  • 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 prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

  • mouth problems occur
  • persistent indigestion or severe sore throat occurs
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, 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.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

 Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours

Other information

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate,  sodium carbonate, sucralose,xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO NICORETTE® LOZENGE active ingredient*

Nicotine Lozenges

Nicotine Polacrilex, 2 mg

Stop Smoking Aid

2 mg

Mint Flavor

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex 2 mg Lozenge.

LOZENGES

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Lozenge.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Package Label

Nicotine Polacrilex USP, 2 mg

LEADER Nicotine Lozenges 2 mg Mint Flavor

NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0562
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code A627
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0562-13 in 1 BOX07/01/2020
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20920607/01/2020
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022
Document Id: 80a9a13d-3966-4433-b92b-e1af1519b840
Set id: 80195d3b-9341-4354-8a65-b5b080b524d0
Version: 3
Effective Time: 20221020
 
Cardinal Health (Leader) 70000