RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR- nicotine polacrilex gum, chewing 
Rugby Laboratories, Inc.

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Nicotine Polacrilex Gum 2 mg and 4 mg MINT - 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

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, xylitol.

Inactive ingredients - 4 mg

carnauba wax, flavors, gum base, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, xylitol.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel 2 mg

Compare to the active ingredient in Nicorette® Gum*

Nicotine Gum

Nicotine Polacrilex Gum USP, 2 m (Nicotine)

Stop Smoking Aid

2 mg

Uncoated Mint 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 Polacrilx 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 Haleon group of companies, distributor of Nicorette® Gum.

BLISTER 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 Uncoated Mint 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

Uncoated Mint 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 Haleon group of Companies, distributor of Nicorette® Gum.

BLISTER 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 Uncoated Mint Flavor

RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1362
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorwhite (off-white to tan) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1362-342 in 1 CARTON07/29/2004
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-1362-065 in 1 CARTON07/29/2004
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0536-1362-2311 in 1 CARTON07/29/2004
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07656907/29/2004
RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1372
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorwhite (off-white to tan) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1372-342 in 1 CARTON07/29/2004
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-1372-065 in 1 CARTON07/29/2004
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0536-1372-2311 in 1 CARTON07/29/2004
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07656807/29/2004
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 3/2024
Document Id: 79a8179e-b3fb-4438-98c8-57d4406f05b2
Set id: 0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25
Version: 13
Effective Time: 20240311
 
Rugby Laboratories, Inc.