RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR- nicotine polacrilex gum, chewing 
ATLANTIC BIOLOGICALS CORP.

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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.

DISTRIBUTED BY:
ALTANTIC BIOLOGICALS CORP.
20101 N.E 16 th PLACE 
MIAMI, FL 33179

Questions or comments?

Call 1-877-440-7867

TO INCREASE YOUR SUCCESS IN QUITTING:

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.

•Not for sale to those under 18 years of age.
•Proof of age required.
•Not for sale in vending machines or from any source where proof of age cannot be verified.

PRINCIPAL DISPLAY PANEL - 2 mg

ATLANTIC BIOLOGICALS CORP.

NDC 17856-3030-1                 

COMPARE TO THE ACTIVE INGREDIENTS OF NICORETTE® GUM*

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

4 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, 2 mg

50 chewing pieces

image description

RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-3030(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)  
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containSUCROSE (UNII: C151H8M554)
Product Characteristics
ColorYELLOW (yellowish) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-3030-150 in 1 CASE04/17/2024
1NDC:17856-3030-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07470706/05/2018
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-3030)

Revised: 4/2024
Document Id: 3e2e5a9e-d331-4920-8594-2eca5547144c
Set id: 57e08517-4c8a-487a-bfbe-2a43f105f4b9
Version: 4
Effective Time: 20240415
 
ATLANTIC BIOLOGICALS CORP.