Package Label

Package Label
SPL v5
SPL
SPL Set ID e7e9c731-2b66-4a1f-a0d3-e12e95012557
Route
ORAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Nicotine polacrilex USP,  4 mg


Medication Information

Indications and Usage

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

Dosage and Administration

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 (about 20 to 30 minutes). 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 (about 20 to 30 minutes) 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.

Description

Nicotine polacrilex USP,  4 mg

Section 42229-5

each lozenge contains : sodium 5 mg store at 20º to 25ºC (68º to 77ºF) keep bottle tightly closed and protect from light

Section 50565-1

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 (1-800-222-1222) right away

Section 50566-9

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)

Section 50568-5

using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Section 50569-3

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

Section 51727-6

acesulfame potassium, colloidal silicon dioxide, cherry flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate,  sodium carbonate, sucralose,xanthan gum

Section 51945-4

Compare to the active ingredient in Nicorette® Lozenge* FREE   |    SUGAR FROM  |   FREE mini Nicotine Lozenges Nicotine Polacrilex Lozenge 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 2 mg Lozenge. CHERRY FLAVOR LOZENGES , 4 mg Each TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks. 3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks. 4. Use With a Support Program as directed in the enclosed User's Guide. 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 not affiliated with, manufactured by or produced by the makers or owners of Nicorette® Lozenge. TAMPER EVIDENT FEATURE: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. RETAIN OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL. PA 17011 www.riteaid.com

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

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.

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine polacrilex USP,  4 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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 (about 20 to 30 minutes). 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 (about 20 to 30 minutes) 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.

Section 42229-5 (42229-5)

each lozenge contains : sodium 5 mg store at 20º to 25ºC (68º to 77ºF) keep bottle tightly closed and protect from light

Section 50565-1 (50565-1)

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 (1-800-222-1222) right away

Section 50566-9 (50566-9)

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)

Section 50568-5 (50568-5)

using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

acesulfame potassium, colloidal silicon dioxide, cherry flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate,  sodium carbonate, sucralose,xanthan gum

Section 51945-4 (51945-4)

Compare to the active ingredient in Nicorette® Lozenge* FREE   |    SUGAR FROM  |   FREE mini Nicotine Lozenges Nicotine Polacrilex Lozenge 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 2 mg Lozenge. CHERRY FLAVOR LOZENGES , 4 mg Each TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks. 3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks. 4. Use With a Support Program as directed in the enclosed User's Guide. 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 not affiliated with, manufactured by or produced by the makers or owners of Nicorette® Lozenge. TAMPER EVIDENT FEATURE: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. RETAIN OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS. DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL. PA 17011 www.riteaid.com

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine polacrilex USP,  4 mg


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