NICOTINE SUGAR FREE- nicotine polacrilex lozenge 
CVS Pharmacy

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex USP, 4 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 right away (1-800-222-1222)

Directions (4 mg lozenge)

 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, flavors, 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 (4 mg lozenge)

Compare to the active ingredient in Nicorette® Lozenge*

Sugar Free

Nicotine Lozenge

Nicotine Polacrilex 4 mg

STOP SMOKING AID

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, 4 mg Each

Mint

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

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

3. Use Long Enough - Use Nicotine mini 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® mini Lozenge.

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

RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket,  RI 02895

Package Label (4 mg lozenge)

Nicotine Polacrilex USP 4 mg

CVS HEALTH Sugar Free Nicotine Lozenge Mint Flavor

NICOTINE  SUGAR FREE
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-858
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MANNITOL (UNII: 3OWL53L36A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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
ShapeOVALSize10mm
FlavorMINTImprint Code A754
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-858-687 in 1 BOX04/30/2019
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69842-858-964 in 1 BOX04/30/2019
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:69842-858-482 in 1 BOX04/30/2019
324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:69842-858-241 in 1 BOX04/30/2019
424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20920604/30/2019
Labeler - CVS Pharmacy (062312574)

Revised: 11/2022
Document Id: 0937c3fe-baba-4460-a6b3-51676cbcafad
Set id: a275ff04-4078-4783-932b-dde9aee04682
Version: 5
Effective Time: 20221122
 
CVS Pharmacy