Label: NICOTINE MINI- nicotine polacrilex lozenge
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NDC Code(s):
72888-186-53,
72888-186-54,
72888-186-55,
72888-186-56, view more72888-187-53, 72888-187-54, 72888-187-55, 72888-187-56
- Packager: Advagen Pharma Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
hours1 lozenge every 2 to 4
hours1 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
hours1 lozenge every 2 to 4
hours1 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
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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
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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
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INGREDIENTS AND APPEARANCE
NICOTINE MINI
nicotine polacrilex lozengeProduct 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 lozengeProduct 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)