Active Ingredient (In Each Chewing Piece)
Nicotine polacrilex (equal to 4mg nicotine)
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Nicorette (NDC 0135-0241). 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), purpose, use, if you are pregnant or breast feeding, only use this medicine on the advice of your health care provider., ask a doctor before use if you have, ask a doctor or a pharmacist before use if you are, stop use and ask a doctor if, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nicotine polacrilex (equal to 4mg nicotine)
Stop smoking aid
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 to 2 hours | 1 piece every 2 to 4 hours | 1 piece every 4 to 8 hours |
each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol
call toll-free 1-800-419-4766 (English/Spanish) weekdays (9:00 am - 4:30 pm ET)
TO INCREASE YOUR SUCCESS IN QUITTING:
To remove the gum, tear off single unit.
Peel off backing, starting at corner with loose edge.
Push gum through foil.
This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.
Distributed by
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in Sweden
NICORETTE, NICORETTE FRUIT CHILL and the NICORETTE sunburst design are registered trademarks of the GlaxoSmithKline group of companies.
For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.
Free Audio CD upon request. See inside.
NDC 0135-0241-05
Nicorette®
nicotine polacrilex gum, 2mg • stop smoking aid
Gum
Coated
FOR BOLD FLAVOR
Fruit Chill™
2 mg
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 Nicorette 4mg Gum
160 PIECES, 2mg EACH
©2014 GSK
30856XF
NDC 0135-0242-05
Nicorette®
Nicotine polacrilex gum, 4mg • stop smoking aid
Gum
Coated
FOR BOLD FLAVOR
Fruit Chill™
4 mg
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 Nicorette 2mg Gum
160 PIECES, 4mg EACH
©2014 GSK
30857XF
* Please review the disclaimer below.