NICOTAC NICOTINE POLACRILEX COATED FRUIT- nicotine gum, chewing 
Lil' Drug Store Products, Inc.

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Nicotac™ Nicotine Polacrilex Gum, 2mg
Coated Fruit

Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex 2 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

  • a sodium-restricted diet
  • heart disease, a 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, teeth, or jaw problems occur
  • 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. 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

Other information

Inactive ingredients

acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium oxide, xylitol

Questions or comments?

call 1-877-440-7867

Distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 2 mg Gum Blister Pack Carton

NICOTAC™
NICOTINE POLACRILEX GUM USP

2
mg
(nicotine)
STOP SMOKING AID

Coated

Fruit Gum

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

Compare to the active ingredient in
Nicorette® Fruit Chill™ Coated Gum*

10 Pieces
Sugar Free, 2 mg Each

Principal Display Panel - 2 mg Gum Blister Pack Carton
NICOTAC NICOTINE POLACRILEX  COATED FRUIT
nicotine gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9805
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)  
Carnauba Wax (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
Magnesium Oxide (UNII: 3A3U0GI71G)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Sodium Carbonate (UNII: 45P3261C7T)  
Sucralose (UNII: 96K6UQ3ZD4)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Xylitol (UNII: VCQ006KQ1E)  
Product Characteristics
ColorYELLOW (Light Yellow) Scoreno score
ShapeSQUARESize14mm
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9805-510 in 1 CARTON10/15/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904404/03/2018
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 12/2019
Document Id: bb4cbbe5-91d2-4dff-bc13-0a4bdf3b30a6
Set id: e910cdf1-306a-4699-81ef-32b5284eabbf
Version: 2
Effective Time: 20191210
 
Lil' Drug Store Products, Inc.