Active Ingredient (In Each Chewing Piece) - 2 Mg
Nicotine Polacrilex 2 mg (nicotine)
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Rugby Nicotine Polacrilex Gum, Original Flavor (NDC 17856-3030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each chewing piece) - 2 mg, active ingredient (in each chewing piece) - 4 mg, purpose, use, warnings, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nicotine Polacrilex 2 mg (nicotine)
Nicotine Polacrilex 4 mg (nicotine)
Stop smoking aid
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.
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 right away.
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
1 piece every | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
1 piece every | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.
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 and talc.
Questions or comments?
Call 1-877-440-7867
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.
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 mg
50 chewing pieces
* Please review the disclaimer below.