NICOTINE MINI- nicotine polacrilex lozenge 
Rugby Laboratories, Inc.

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex 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

  • 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 (2 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 1-800-645-2158

Principal Display Panel (2 mg lozenge)

Compare to the active ingredient in Nicorette® mini Lozenge*

NICOTINE

mini Lozenge

Nicotine polacrilex  2 mg

Stop Smoking Aid

Mint Flavor

2 mg

User's Guide Included

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

LOZENGES, 2 mg Each (Vials)

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 detail or visit www.nixthehabit.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:

RUGBY® LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com


Package Label (2 mg lozenge)

Nicotine Polacrilex 2 mg

RUGBY Nicotine Mini Lozenge

NICOTINE MINI 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1239
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 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 129
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1239-813 in 1 BOX07/31/2019
127 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0536-1239-271 in 1 BOX07/31/2019
227 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20786807/31/2019
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 3/2024
Document Id: de4aaec2-2cba-44eb-9d3f-17cf9caacc57
Set id: be17cbe9-43bb-424e-9d91-fba4f02691bb
Version: 4
Effective Time: 20240328
 
Rugby Laboratories, Inc.