Label: RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR- nicotine polacrilex gum, chewing
- NDC Code(s): 17856-3030-1, 17856-3030-2
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0536-3030
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 15, 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) - 2 mg
- Active ingredient (in each chewing piece) - 4 mg
- 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
- Keep out of reach of children and pets.
-
Directions - 2 mg
- 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
- 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
- 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 this process until most of the tingle is gone (about 30 minutes)
- do not eat or drink for 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.
-
Directions - 4 mg
- 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 more than 30 minutes after waking up, use 2 mg nicotine gum
- if you smoke your first cigarette within 30 minutes of waking up, use 4 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
- 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 this process until most of the tingle is gone (about 30 minutes)
- do not eat or drink for 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 - 2 mg
- Other information - 4 mg
- Inactive ingredients - 2 mg
- Inactive ingredients - 4 mg
- DISTRIBUTED BY:ALTANTIC BIOLOGICALS CORP.20101 N.E 16 th PLACE MIAMI, FL 33179
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TO INCREASE YOUR SUCCESS IN QUITTING:
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.•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. -
PRINCIPAL DISPLAY PANEL - 2 mg
ATLANTIC BIOLOGICALS CORP.
NDC 17856-3030-1
COMPARE TO THE ACTIVE INGREDIENTS OF NICORETTE® GUM*
SUGAR FREE
NICOTINE Polacrilex GUM
USP, 4 mg (nicotine)4 mg ORIGINAL
STOP SMOKING AID
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, 2 mg50 chewing pieces
-
INGREDIENTS AND APPEARANCE
RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-3030(NDC:0536-3030) Route of Administration BUCCAL 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) 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) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) Other Ingredients Ingredient Kind Ingredient Name Quantity Does not contain SUCROSE (UNII: C151H8M554) 0 Product Characteristics Color YELLOW (yellowish) Score no score Shape SQUARE Size 14mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-3030-1 50 in 1 CASE 04/17/2024 1 NDC:17856-3030-2 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074707 06/05/2018 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations UNIT DOSE SOLUTIONS 360804194 repack(17856-3030)