Label: NICOTINE- nicotine polacrilex gum, chewing
- NDC Code(s): 0363-9350-30
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewing piece)
- Purpose
- Use
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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
- 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
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, 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)
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Directions
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Nicorette® Gum active ingredient††
Nicotine Gum
NICOTINE POLACRILEX GUM USP, 4 mg (NICOTINE)
STOP SMOKING AID
SUGAR FREE
ORIGINAL FLAVOR
PIECES 4 MG EACH
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: WALGREEN CO
200 WILMOT RD., DEERFIELD, IL 60015
- Package Label
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INGREDIENTS AND APPEARANCE
NICOTINE
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9350 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) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARNAUBA WAX (UNII: R12CBM0EIZ) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) TALC (UNII: 7SEV7J4R1U) SORBITOL (UNII: 506T60A25R) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color white Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9350-30 300 in 1 CARTON 12/27/2019 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074707 12/27/2019 Labeler - Walgreens (008965063)
