Package Label (4 Mg Lozenge)

Package Label (4 Mg Lozenge)
SPL v6
SPL
SPL Set ID 8bafad28-d671-4ff3-8288-6fd19ae43293
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 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. 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.

Description

Nicotine polacrilex 4 mg

Section 42229-5

Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge store at 20-25ºC (68-77ºF) 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

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

Section 51945-4

Compare to the active ingredient in Nicorette® mini Lozenge* FREE   |   SUGAR FROM  |    FREE Min i Nicotine Lozenge Nicotine Polacrilex 4 mg Stop Smoking Aid Mint Flavor 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. LOZENGES , 4 mg Each (Vials) TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks. 3. Use Long Enough - Use Nicotine mini 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 manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® mini Lozenge. See inside for more details or visit www.nitthehabit.com TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. 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 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. 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.

Section 42229-5 (42229-5)

Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge store at 20-25ºC (68-77ºF) 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)

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

Section 51945-4 (51945-4)

Compare to the active ingredient in Nicorette® mini Lozenge* FREE   |   SUGAR FROM  |    FREE Min i Nicotine Lozenge Nicotine Polacrilex 4 mg Stop Smoking Aid Mint Flavor 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. LOZENGES , 4 mg Each (Vials) TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks. 3. Use Long Enough - Use Nicotine mini 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 manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® mini Lozenge. See inside for more details or visit www.nitthehabit.com TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. 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 4 mg


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