MINI NICOTINE- nicotine polacrilex lozenge 
WALMART INC. (see also Equate)

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex 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

  • 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 (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

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions or comments?

Call 1-888-287-1915

Principal Display Panel (4 mg lozenge)

Compare to Nicorette® Mini Lozenge active ingredient*

MINI

Nicotine Lozenges

Nicotine Polacrilex Lozenges, 4 mg (Nicotine)

Stop Smoking Aid

Sugar-Free

Includes User's Guide

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 Lozenge 2 mg.

LOZENGES, 4 mg

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.

See inside for more details or visit www.nitthehabit.com

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: Walmart Inc.,

Bentonville, AR 72716

 

Package Label (4 mg lozenge)

Nicotine Polacrilex 4 mg

EQUATE Mini Nicotine Lozenges Mint Flavor

MINI NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize10mm
FlavorMINTImprint Code 131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79903-128-084 in 1 BOX07/01/2022
127 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:79903-128-271 in 1 BOX07/01/2022
227 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20786807/01/2022
Labeler - WALMART INC. (see also Equate) (051957769)

Revised: 9/2023
Document Id: c8e52227-cd3f-43e3-9717-3280551e1109
Set id: 286e2768-ad98-43be-a3be-a2db0370f50f
Version: 7
Effective Time: 20230919
 
WALMART INC. (see also Equate)