Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 31e0dadd-2678-4e3c-9e62-e3766c21ce5f
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (2 mg)
Inactive Ingredients
Aspartame Calcium Polycarbophil Maltodextrin Mannitol Sodium Alginate Sodium Bicarbonate Sodium Stearyl Fumarate Talc Xanthan Gum

Identifiers & Packaging

Pill Appearance
Imprint: 129 Shape: oval Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-07-31

Description

Nicotine polacrilex 2 mg

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine polacrilex 2 mg

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Other Information
  • Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge
  • store at 20-25ºC (68-77ºF)
  • keep vial tightly closed and protect from light
Inactive Ingredients

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions Or Comments?

Call 1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICAL CORPS. 

MIAMI, FL 33179   

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.
Package Label (2 Mg Lozenge)

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)
Active Ingredient (in Each Lozenge)

Nicotine polacrilex 2 mg

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
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.

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 (1-800-222-1222).

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.

Structured Label Content

Use
  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose

Stop smoking aid

Other Information (Other information)
  • Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge
  • store at 20-25ºC (68-77ºF)
  • keep vial tightly closed and protect from light
Inactive Ingredients (Inactive ingredients)

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICAL CORPS. 

MIAMI, FL 33179   

Directions (2 Mg Lozenge) (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.
Package Label (2 Mg Lozenge) (Package Label (2 mg lozenge))

Stop Use and Ask A Doctor If (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)
Active Ingredient (in Each Lozenge) (Active ingredient (in each lozenge))

Nicotine polacrilex 2 mg

Ask A Doctor Before Use If You Have (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
If You Are Pregnant Or Breast Feeding, (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.

Keep Out of Reach of Children and Pets. (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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If You Are (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.

Advanced Ingredient Data


Raw Label Data

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