Active Ingredient (In Each Chewing Piece)
Nicotine polacrilex 4 mg
The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Nicotine (NDC 30142-671). 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,, 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Nicotine polacrilex 4 mg
Stop smoking aid
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 (1-800-222-1222) 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 |
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, talc
Call 1-800-632-6900
*COMPARE TO the active ingredient in NICORETTE® GUM
Uncoated
Nicotine Gum
Nicotine Polacrilex Gum USP, 4 mg (nicotine)
STOP SMOKING AID
Includes User's Guide
Uncoated Original Gum
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 (nicotine)
Sugar-free
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.
To remove the gum, tear off single unit.
Peel off backing starting at corner with loose edge.
Push gum through foil
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum
See inside for more details or visit www.nitthehabit.com
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN
DISTRIBUTED BY THE KROGER CO.,
CINCINNATI, OHIO 45202
* Please review the disclaimer below.