NICOTINE MINI- nicotine polacrilex lozenge

Nicotine Mini by

Drug Labeling and Warnings

Nicotine Mini by is a Otc medication manufactured, distributed, or labeled by Advagen Pharma Limited, Rubicon Research Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient (in each lozenge)

Nicotine polacrilex 4 mg

Nicotine polacrilex 2 mg

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

• heart disease, 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 problems occur
• persistent indigestion or severe sore throat occurs
• 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.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (4 mg lozenge)

• if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
• before using this product, read the enclosed User's Guide for complete directions and other important information
• begin using the lozenge on your quit day
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2; hours	1 lozenge every 2 to 4; hours	1 lozenge every 4 to 8; hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results
• place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
• you may feel a warm or tingling sensation
• occasionally move the lozenge from one side of your mouth to the other until completely dissolved
• do not eat or drink 15 minutes before using or while the lozenge is in your mouth
• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
• It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Directions (2 mg lozenge)

• if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
• before using this product, read the enclosed User's Guide for complete directions and other important information
• begin using the lozenge on your quit day
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2; hours	1 lozenge every 2 to 4; hours	1 lozenge every 4 to 8; hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results
• place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
• you may feel a warm or tingling sensation
• occasionally move the lozenge from one side of your mouth to the other until completely dissolved
• do not eat or drink 15 minutes before using or while the lozenge is in your mouth
• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
• It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other information

• Each lozenge contains: sodium, 5 mg
• store at 20 o to 25 oC (68 o to 77 oF)
• keep bottle tightly closed and protect from light
• TAMPER EVIDENT FEATURE: Do not use if printed seal under cap is broken or missing. retain outer carton for full product uses, directions and warnings.

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose, and xanthan gum.

Questions or comments?

Call 866-488-0312 Monday-Friday 9AM-5PM EST

Manufactured by

Rubicon Research Pvt. Ltd
Ambernath, Maharashtra 421 506, India

Manufactured for

Advagen Pharma Limited,
666 Plainsboro Road, Suite 605
Plainsboro, NJ 08536, USA

Revised - April 2023

ACTIVE INGREDIENT

INACTIVE INGREDIENT

DOSAGE & ADMINISTRATION

WARNINGS

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Polacrilex Lozenge, 2 mg - NDC: 72888-186-53 - 27s Container Label

Nicotine Polacrilex Lozenge, 2 mg - NDC: 72888-186-53 - 27s Carton Label

Nicotine Polacrilex Lozenge, 2 mg - NDC: 72888-186-54 - 81s Carton Label

Nicotine Polacrilex Lozenge, 2 mg - NDC: 72888-186-55 - 108s Carton Label

Nicotine Polacrilex Lozenge, 2 mg - NDC: 72888-186-56 - 135s Carton Label

PRINCIPAL DISPLAY PANEL

Nicotine Polacrilex Lozenge, 4 mg - NDC: 72888-187-53 - 27s Container Label

Nicotine Polacrilex Lozenge, 4 mg - NDC: 72888-187-53 - 27s Carton Label

Nicotine Polacrilex Lozenge, 4 mg - NDC: 72888-187-54 - 81s Carton Label

Nicotine Polacrilex Lozenge, 4 mg - NDC: 72888-187-55 - 108s Carton Label

Nicotine Polacrilex Lozenge, 4 mg - NDC: 72888-187-56 - 135s Carton Label

INGREDIENTS AND APPEARANCE

NICOTINE MINI 
nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72888-186
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONE (UNII: FZ989GH94E)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (White to Off-white)	Score	no score
Shape	OVAL	Size	11mm
Flavor	MINT	Imprint Code	A516
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72888-186-53	1 in 1 CARTON	04/14/2023
1		27 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72888-186-54	3 in 1 CARTON	04/14/2023
2		27 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 72888-186-55	4 in 1 CARTON	04/14/2023
3		27 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 72888-186-56	5 in 1 CARTON	04/14/2023
4		27 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208875	04/14/2023

NICOTINE MINI 
nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72888-187
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
POVIDONE (UNII: FZ989GH94E)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (White to Off-white)	Score	no score
Shape	OVAL	Size	11mm
Flavor	MINT	Imprint Code	A435
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72888-187-53	1 in 1 CARTON	04/14/2023
1		27 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72888-187-54	3 in 1 CARTON	04/14/2023
2		27 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 72888-187-55	4 in 1 CARTON	04/14/2023
3		27 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 72888-187-56	5 in 1 CARTON	04/14/2023
4		27 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208875	04/14/2023

Labeler - Advagen Pharma Limited (051627256)

Establishment
Name	Address	ID/FEI	Business Operations
Rubicon Research Private Limited		677604197	analysis(72888-186, 72888-187) , label(72888-186, 72888-187) , manufacture(72888-186, 72888-187)