NICOTINE POLACRILEX COATED MINT- nicotine polacrilex gum, chewing

Nicotine Polacrilex by

Drug Labeling and Warnings

Nicotine Polacrilex by is a Otc medication manufactured, distributed, or labeled by Roman Health Ventures Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

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
• 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 - 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
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

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
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg 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. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information - 2 mg

• each piece contains: calcium 115 mg, sodium 8 mg
• store at 20 - 25ºC (68 - 77ºF)
• protect from light

Other information - 4 mg

• each piece contains: calcium 120 mg, sodium 8 mg
• store at 20 - 25ºC (68 - 77ºF)
• protect from light

Inactive ingredients - 2 mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-877-440-7867

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.

   

Blister packaged for your protection.
Do not use if individual seals are open or torn.

• 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.

FREE AUDIO CD
Upon Request.
See Inside.

 

 

 

Principal Display Panel - 2 mg

ZERO

Compare to the active ingredient in Nicorette ® Fresh Mint TM Coated Gum*

Sugar Free

Nicotine Polacrilex
Gum USP, 2 mg (nicotine)

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

Coated Mint

160 Pieces, 2 mg Each

Principal Display Panel - 4 mg

ZERO

Compare to the active ingredient in Nicorette ® Fresh Mint TM Coated Gum*

Sugar Free

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 USP, 2 mg

Coated Mint

160 Pieces, 4 mg Each

INGREDIENTS AND APPEARANCE

NICOTINE POLACRILEX  COATED MINT
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72484-428
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72484-428-16	160 in 1 CARTON	10/08/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078699	10/08/2018

NICOTINE POLACRILEX  COATED MINT
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72484-429
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	yellow	Score	no score
Shape	SQUARE	Size	14mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72484-429-16	160 in 1 CARTON	10/08/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078697	10/08/2018

Labeler - Roman Health Ventures Inc. (081317350)