Label: NICOTINE POLACRILEX gum, chewing
- NDC Code(s): 57237-322-01
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 31, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- 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
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
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Directions
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if you are under 18 years of age, ask a doctor before use
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before using this product, read the enclosed User's Guide for complete directions and other important information
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begin using the gum on your quit day
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if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
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if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:
Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every
1 to 2 hours1 piece every
2 to 4 hours1 piece every
4 to 8 hours-
nicotine gum is a medicine and must be used a certain way to get the best results
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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.
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repeat this process until most of the tingle is gone (about 30 minutes)
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do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
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to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
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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.
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do not use more than 24 pieces a day
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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.
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- Other information
- Questions or comments?
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Principal Display Panel (2 mg Gum)
*Compare to the active ingredient in Nicorrette® Gum
Nicotine Gum
Stop Smoking Aid
NICOTINE POLACRILEX GUM USP, 2 MG (NICOTINE)
- FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.
- If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicotine Polacrilex Gum USP, 4 mg
- Sugar Free
- Gluten Free
2 mg
Coated Mint Flavor
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivate 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.
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.
- 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 Haleon group of companies, distributor of Nicorette® Gum.
- Package Label (2 mg Gum)
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INGREDIENTS AND APPEARANCE
NICOTINE POLACRILEX
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 2 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white Score no score Shape SQUARE Size 14mm Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-322-01 100 in 1 CARTON 08/10/2023 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 ANDA078699 08/10/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)