NICOTINE POLACRILEX- nicotine polacrilex gum, chewing 
Kroger Company

----------

Drug Facts

Active ingredient (in each chewing piece) 2 mg

Nicotine polacrilex (equal to 2mg nicotine)

Active ingredient (in each chewing piece) 4 mg

Nicotine polacrilex (equal to 4mg nicotine)

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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.

Do not use

if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

a sodium-restricted diet
heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
high blood pressure not controlled with medication. Nicotine can increase blood pressure.
stomach ulcer or diabetes

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 (2 mg)

if you are under 18 years of age, ask a doctor before use
before using this product, read the enclosed User's Guide for complete directions and other important information
stop smoking completely when you begin using the gum
if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine gum
if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine gum according to the following 12 week schedule:

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

nicotine gum is a medicine and must be used a certain way to get the best results
chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
repeat this process until most of the tingle is gone (about 30 minutes)
do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

Directions (4 mg)

if you are under 18 years of age, ask a doctor before use
before using this product, read the enclosed User's Guide for complete directions and other important information
stop smoking completely when you begin using the gum
if you smoke your first cigarette more than 30 minutes after waking up, use 2mg nicotine gum
if you smoke your first cigarette within 30 minutes of waking up, use 4mg nicotine gum according to the following 12 week schedule:

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

nicotine gum is a medicine and must be used a certain way to get the best results
chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
repeat this process until most of the tingle is gone (about 30 minutes)
do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.

Other information (2 mg Mint Coated)

each piece contains: calcium 94mg, sodium 11mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (4 mg Mint Coated)

each piece contains: calcium 94mg, sodium 13mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (2 mg Fruit Wave)

each piece contains: calcium 94mg, sodium 11mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (4 mg Fruit Wave)

each piece contains: calcium 94mg, sodium 13mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (2 mg Mint Uncoated)

each piece contains: calcium 94mg, sodium 13mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (4 mg Mint Uncoated)

each piece contains: calcium 94mg, sodium 14mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (2 mg Original Uncoated)

each piece contains: calcium 117mg, sodium 13 mg
store at 20 - 25°C (68 - 77°F)
protect from light

Other information (4 mg Original Uncoated)

each piece contains: calcium 117mg, sodium 13mg
store at 20 - 25°C (68 - 77°F)
protect from light

Inactive ingredients (2 mg Mint Coated)

acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

Inactive ingredients (4 mg Mint Coated)

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

Inactive ingredients (2 mg Fruit Wave)

acacia, acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (4 mg Fruit Wave)

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (2 mg Mint Uncoated)

acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

Inactive ingredients (4 mg Mint Uncoated)

acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (2 mg Original Uncoated)

flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

Inactive ingredients (4 mg Original Uncoated)

D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Questions or comments?

call toll-free 1-800-491-1830 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)

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.

To remove the gum, tear off single unit.

Peel off backing starting at corner with loose edge.

Push gum through foil.

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

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

*NICORETTE is a registered trademark of GlaxoSmithKline group of companies, Wilmington, DE 19808.

GlaxoSmithKline group of companies is not affiliated with The Kroger Co.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202, Made in Sweden

QUALITY GUARANTEED

If you are not completely satisfied with this product, return it for a refund or replacement.

Free Audio CD upon request. See inside.

Principal Display Panel

NDC 30142-916-03

Nicotine polacrilex Gum, 2mg

Kroger®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Mint Gum

100 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® FRESH MINT™ GUM

*See side panel

COATED GUM

©2012

101472XB

Mint coated 2mg Kroger carton

Principal Display Panel

NDC 30142-918-03

Nicotine polacrilex Gum, 4mg

Kroger®

QUALITY GUARANTEED

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

ACTUAL SIZE

Mint Gum

100 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® FRESH MINT™ GUM

*See side panel

COATED GUM

©2012

101473XC

Mint coated 4mg Kroger carton

Principal Display Panel

NDC 30142-914-03

Nicotine polacrilex Gum, 2mg

Kroger®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Fruit Wave Gum

COATED FOR BURSTING FLAVOR

100 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® FRUIT CHILL™ GUM

*See side panel

COATED GUM

©2012

101470XB

Fruit Wave 2mg Kroger carton

Principal Display Panel

NDC 30142-915-03

Nicotine polacrilex Gum, 4mg

Kroger®

QUALITY GUARANTEED

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

ACTUAL SIZE

Fruit Wave Gum

COATED FOR BURSTING FLAVOR

100 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® FRUIT CHILL™ GUM

*See side panel

COATED GUM

©2012

101471XB

Nicotine Polacrilex 4mg Fruit Wave 100 count Kroger carton

Principal Display Panel

NDC 30142-912-02

Nicotine polacrilex Gum, 2mg

Kroger®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Mint Gum

110 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® MINT GUM

*See side panel

UNCOATED GUM

©2012

101468XB

Mint uncoated 2mg Kroger carton

Principal Display Panel

NDC 30142-913-02

Nicotine polacrilex Gum, 4mg

Kroger®

QUALITY GUARANTEED

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

ACTUAL SIZE

Mint Gum

110 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® MINT GUM

*See side panel

UNCOATED GUM

©2012

101469XB

Mint uncoated 4mg Kroger carton

Principal Display Panel

NDC 30142-910-02

Nicotine polacrilex Gum, 2mg

Kroger®

QUALITY GUARANTEED

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, 4 mg

ACTUAL SIZE

Original Gum

110 PIECES, 2 mg each

COMPARE TO active ingredient in NICORETTE® ORIGINAL GUM

*See side panel

UNCOATED GUM

©2012

101466XB

Original uncoated 2mg Kroger carton

Principal Display Panel

NDC 30142-911-02

Nicotine polacrilex Gum, 4mg

Kroger®

QUALITY GUARANTEED

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

Original Gum

110 PIECES, 4 mg each

COMPARE TO active ingredient in NICORETTE® ORIGINAL GUM

*See side panel

UNCOATED GUM

©2011

101467XB

Nicotine Gum Original Uncoated 4 mg 110 count Kroger carton
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-916
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITE (Beige) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code N2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-916-0310 in 1 CARTON07/26/201101/26/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861207/26/201101/26/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-918
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorYELLOWScoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code N4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-918-0310 in 1 CARTON08/17/201101/07/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006608/17/201101/07/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-914
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITE (Beige) Scoreno score
ShapeSQUARESize14mm
FlavorFRUIT (Fruit Wave) Imprint Code N2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-914-0310 in 1 CARTON08/04/201104/02/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861208/04/201104/02/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-915
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorYELLOWScoreno score
ShapeSQUARESize14mm
FlavorFRUIT (Fruit Wave) Imprint Code N4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-915-0310 in 1 CARTON08/04/201102/23/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006608/04/201102/23/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-912
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITE (Beige) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-912-0211 in 1 CARTON08/04/201101/15/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861208/04/201101/15/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-913
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorYELLOWScoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-913-0211 in 1 CARTON08/04/201102/16/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006608/04/201102/16/2018
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-910
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (Beige) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-910-0211 in 1 CARTON08/04/201105/04/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861208/04/201105/04/2017
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-911
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorYELLOWScoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-911-0211 in 1 CARTON08/04/201108/10/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006608/04/201108/10/2017
Labeler - Kroger Company (006999528)
Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2018
 
Kroger Company