NICOTINE- nicotine polacrilex lozenge 
Rite Aid Corporation

----------

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, cherry 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 the active ingredient in Nicorette® Lozenge*

Nicotine Lozenges

Nicotine Polacrilex Lozenge

Stop Smoking Aid

Sugar Free

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex 4 mg Lozenge.

CHERRY FLAVOR, 2 mg Each

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 SEAL UNDER CAP IS BROKEN OR MISSING.

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

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL. PA 17011

www.riteaid.com

Package Label

Nicotine Polacrilex Lozenge Stop Smoking Aid

Nicotine Lozenges 2 mg Cherry Flavor

NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3379
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
FlavorCHERRYImprint Code A613
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-3379-53 in 1 BOX06/09/2021
1NDC:11822-3379-624 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21071203/18/2020
Labeler - Rite Aid Corporation (014578892)

Revised: 2/2023
Document Id: 2269ad84-797d-4191-9d6a-2def628b2669
Set id: bafc7058-f74f-4c2f-bbc5-3304d3d344b5
Version: 7
Effective Time: 20230221
 
Rite Aid Corporation