Package Label

Package Label
SPL v5
SPL
SPL Set ID 1cf7f1b0-58ae-4a71-9841-b580f31cf1d0
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 before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: if you smoke your first cigarette more than 30 minutes after waking up , use 2 mg nicotine gum  Weeks 1 to 6  Weeks 7 to 9  Weeks 10 to 12  1 piece every 1 to 2 hours  1 piece every 2 to 4 hours  1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.  repeat the process until most of the tingle is gone (about 30 minutes) do not eat or drink 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day It is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Description

Nicotine polacrilex 4 mg

Section 42229-5

each piece contains : calcium 110 mg, sodium 11 mg store at 20-25ºC (68-77ºF) protect from light

Section 50565-1

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum 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, teeth, or jaw problems occur 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

a sodium-restricted diet 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, butylated hydroxytoluene, carnauba wax, D & C yellow #10 lake, FD & C blue #2 lake, FD & C red #40, FD & C Yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc

Section 51945-4

Compare to the active ingredient of Nicorette® Gum* FREE  |  SUGAR FROM  |  FREE  Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (nicotine) Stop Smoking Aid ORIGINAL FLAVOR FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES OF WAKING UP. If you smoke your first cigarette WITHIN 30 MINUTES  after waking up, use Nicotine Polacrilex Gum USP, 2 mg TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks. 3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks. 4. Use With a Support Program as directed in the enclosed User's Guide. To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil 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® Gum See inside for more details or visit www.nitthehabit.com BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN 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 before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule: if you smoke your first cigarette more than 30 minutes after waking up , use 2 mg nicotine gum  Weeks 1 to 6  Weeks 7 to 9  Weeks 10 to 12  1 piece every 1 to 2 hours  1 piece every 2 to 4 hours  1 piece every 4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best results chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.  repeat the process until most of the tingle is gone (about 30 minutes) do not eat or drink 15 minutes before chewing the nicotine gum, or while chewing a piece to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. do not use more than 24 pieces a day It is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Section 42229-5 (42229-5)

each piece contains : calcium 110 mg, sodium 11 mg store at 20-25ºC (68-77ºF) protect from light

Section 50565-1 (50565-1)

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum 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, teeth, or jaw problems occur 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)

a sodium-restricted diet 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, butylated hydroxytoluene, carnauba wax, D & C yellow #10 lake, FD & C blue #2 lake, FD & C red #40, FD & C Yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc

Section 51945-4 (51945-4)

Compare to the active ingredient of Nicorette® Gum* FREE  |  SUGAR FROM  |  FREE  Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (nicotine) Stop Smoking Aid ORIGINAL FLAVOR FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES OF WAKING UP. If you smoke your first cigarette WITHIN 30 MINUTES  after waking up, use Nicotine Polacrilex Gum USP, 2 mg TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks. 3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks. 4. Use With a Support Program as directed in the enclosed User's Guide. To remove the gum, tear off single unit. Peel off backing starting at corner with loose edge. Push gum through foil 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® Gum See inside for more details or visit www.nitthehabit.com BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN 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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