NICOTINE- nicotine polacrilex gum, chewing 
McKesson Corporation dba SKY Packaging

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Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate

Drug Facts

Active ingredient (in each chewing piece)

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

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

Inactive ingredients

acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C blue #2, FD&C red #40, FD&C yellow #6, gum base, hydroxypropyl cellulose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-877-440-7867

Principal Display Panel

*Compare to the active ingredient of Nicorrette® Gum

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

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, 2 mg

Sugar Free

COATED FRUIT FLAVOR

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivate 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

To remove the gum, tear off single unit

Peel off backing starting at corner with loose edge

Push gum through foil

*Nicorette is a trademark of GlaxoSmithKline Consumer Healthcare L.P.

*This product is not affiliated with GlaxoSmithKline Consumer Healthcare, L.P.

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

Distributed By:

McKesson Corporation dba SKY packaging

4971 Southridge Blvd. Suite 101, Memphis, TN 38141

Package Label

Nicotine Polacrilex 4 mg (nicotine)

SKY Nicotine Polacrilex Gum Fruit Flavor

NICOTINE 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-368
Route of AdministrationORAL
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)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize14mm
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-368-10100 in 1 CARTON04/27/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07903804/27/2020
Labeler - McKesson Corporation dba SKY Packaging (140529962)

Revised: 10/2023
Document Id: a234250a-9bc8-4a21-a13f-021658e1573a
Set id: 0d53243f-f1a7-4a1d-a93e-c0a8f05ed8df
Version: 3
Effective Time: 20231012
 
McKesson Corporation dba SKY Packaging