NICOTINE POLACRILEX- nicotine polacrilex gum, chewing 
Rugby Laboratories, Inc.

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Nicotine Polacrilex Gum 2 mg and 4 mg Coated Cinnamon - Rugby

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

Nicotine Polacrilex 4 mg (nicotine)

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

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum 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 - 2 mg

  Weeks 1 to 6    Weeks 7 to 9    Weeks 10 to 12 

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours 
1 piece every
4 to 8 hours

Directions - 4 mg

  Weeks 1 to 6    Weeks 7 to 9    Weeks 10 to 12 

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours 
1 piece every
4 to 8 hours

Other information - 2 mg

Other information - 4 mg

Inactive ingredients - 2 mg

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-800-645-2158

Principal display panel 2 mg

Compare to the active ingredient in Nicorette® Gum*

Nicotine Gum

Nicotine Polacrilex Gum USP, 2 mg (Nicotine)

Stop Smoking Aid

2 mg

Coated Cinnamon Flavor 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 Gum USP, 4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be Motivated to quit

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum 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® Gum.

BLISTERED PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Package label 2 mg

Nicotine Polacrilex 2 mg (nicotine)

RUGBY Nicotine Gum Coated Cinnamon Flavor

Principal display panel 4 mg

Compare to the active ingredient in Nicorette® Gum*

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (Nicotine)

Stop Smoking Aid

4 mg

Coated Cinnamon Flavor

Sugar-Free

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 Gum USP, 2 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2 Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum 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® Gum.

BLISTERED PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

RUGBY Nicotine Gum Coated Cinnamon Flavor

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3404
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorpink (light pink) Scoreno score
ShapeSQUARESize14mm
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3404-3740 in 1 CARTON07/08/200908/31/2014
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-3404-01100 in 1 CARTON07/08/2009
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921607/08/2009
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3405
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorpink (dark pink) Scoreno score
ShapeSQUARESize14mm
FlavorCINNAMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3405-3740 in 1 CARTON07/08/200907/31/2015
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-3405-01100 in 1 CARTON07/08/2009
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921907/08/2009
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 3/2024
Document Id: eee49e57-775e-4f80-9cd8-ac36f5b124fd
Set id: d67149d5-4766-4b84-8205-f1a6b692f4c9
Version: 12
Effective Time: 20240304
 
Rugby Laboratories, Inc.