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

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Nicotine Polacrilex Gum 2 mg and 4 mg Original Flavor - 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 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

acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Inactive ingredients - 4 mg

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil.

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.


PRINCIPAL DISPLAY PANEL - 2 mg

Rugby®                                          COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3029-06                        IN NICORETTE® GUM*

SUGAR FREE
NICOTINE Polacrilex GUM
USP, 2 mg (nicotine)

2 mg  ORIGINAL

STOP SMOKING AID

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

50 chewing pieces


2 mg 50 count original

 

PRINCIPAL DISPLAY PANEL - 4 mg

Rugby®                                            COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3030-06                          IN NICORETTE® GUM*

SUGAR FREE
NICOTINE Polacrilex GUM
USP, 4 mg (nicotine)

4 mg   ORIGINAL

STOP SMOKING AID

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

50 chewing pieces

4 mg 50 count - original

RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3029
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (off-white to tan) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3029-2311 in 1 CARTON03/15/1999
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-3029-342 in 1 CARTON03/15/1999
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0536-3029-065 in 1 CARTON03/15/1999
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07450703/15/1999
RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3030
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorYELLOW (yellowish) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3030-2311 in 1 CARTON03/19/1999
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-3030-065 in 1 CARTON03/19/1999
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07470703/19/1999
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2020
Document Id: 408d95c8-8c3b-4487-9709-8ca65ddb566e
Set id: 1fc88637-4329-486e-82ab-19eeb06080a6
Version: 13
Effective Time: 20200916
 
Rugby Laboratories, Inc.