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 Rugby Laboratories for the product Rugby Nicotine Polacrilex Gum, Coated Mint Flavor (NDC 0536-3113). 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 |
acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.
acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.
Call 1-877-440-7867
TO INCREASE YOUR SUCCESS IN QUITTING:
Rugby® COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3112-37 IN NICORETTE® FRESH MINT™ COATED GUM*
SUGAR FREE
NICOTINE Polacrilex GUM
USP, 2 mg (nicotine)
2 mg COATED MINT
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, 4 mg
40 chewing pieces
Rugby® COMPARE TO THE ACTIVE INGREDIENT
NDC 0536-3113-37 IN NICORETTE® FRESH MINT™ COATED GUM*
SUGAR FREE
NICOTINE Polacrilex GUM
USP, 4 mg (nicotine)
4 mg COATED MINT
STOP SMOKING AID
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.
If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex Gum USP, 2 mg
40 chewing pieces
* Please review the disclaimer below.