Active Ingredient (In Each Lozenge)
Nicotine polacrilex USP, 4 mg
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Nicotine Mini (NDC 59726-652). 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 lozenge), 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 USP, 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.
Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it 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 lozenge every 1 to 2 hours | 1 lozenge every 2 to 4 hours | 1 lozenge every 4 to 8 hours |
acesulfame potassium, colloidal silicon dioxide, cherry flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose, xanthan gum
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*Compare to the active ingredient in Nicorette® Mini Lozenge
Mini
nicotine lozenge
nicotine polacrilex 4 mg
stop smoking aid
Cherry flavor
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 2 mg Lozenge.
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2.Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks.
3.Use Long Enough - Use Nicotine mini lozenges for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
Gluten Free
Retain outer carton for full product uses, directions and warnings.
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor Nicorette® mini Lozenge.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
* Please review the disclaimer below.