Active Ingredient (In Each Chewing Piece) - 2 Mg
Nicotine Polacrilex (equal to 2 mg nicotine)
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Habitrol Nicotine Polacrilex Gum 2 Mg Coated Fruit (NDC 75907-301). 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, 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, 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 2 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 (1-800-222-1222) 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 |
acacia, acesulfame potassium, carnauba wax, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.
Call toll-free1-800-585-8682 weekdays (8:00 am - 8:00 pm EST
*Compare to the active ingredient of Nicorette® Gum
Habitrol
Nicotine Polacrilex Gum
USP, 2 mg (nicotine )
STOP SMOKING AID
Gum
2 mg
Sugar-free
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 Habitrol 4 mg Gum
COATED FRUIT FLAVOR
TO INCREASE YOUR SUCCESS IN QUITTING:
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEAL ARE OPEN OR TORN.
*This product is not manufactured or distributed by Haleon group of companies, distributor or Nicorette® Gum.
DISTRIBUTED BY:
Dr. Reddy's Laboratories, Inc.
Princeton, NJ 08540
* Please review the disclaimer below.