Label: NICOTAC NICOTINE POLACRILEX COATED FRUIT- nicotine gum, chewing
- NDC Code(s): 66715-9805-5
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 10, 2019
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewing piece)
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.
Ask a doctor before use if you have
- a sodium-restricted diet
- heart disease, a recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
- high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
- stomach ulcer or diabetes
- history of seizures
Ask a doctor or pharmacist before use if you are
- using a non-nicotine stop smoking drug
- taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Stop use and ask a doctor if
- mouth, teeth, or jaw problems occur
- irregular heartbeat or palpitations occur
- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat
- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
- if you are under 18 years of age, ask a doctor before use
- before using this product, read the enclosed User's Guide for complete directions and other important information
- begin using the gum on on your quit day
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:
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
- nicotine gum is a medicine and must be used a certain way to get the best results
- chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
- repeat this process until most of the tingle is gone (about 30 minutes)
- do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
- to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
- If you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause hiccups, heartburn, nausea, or other side effects.
- do not use more than 24 pieces a day
- it is important to complete treatment. If you still feel the need to use the gum for a longer period to keep from smoking, talk to your health care provider.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 2 mg Gum Blister Pack Carton
NICOTINE POLACRILEX GUM USP
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
Compare to the active ingredient in
Nicorette® Fruit Chill™ Coated Gum*
Sugar Free, 2 mg Each
INGREDIENTS AND APPEARANCE
NICOTAC NICOTINE POLACRILEX COATED FRUIT
nicotine gum, chewing
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9805 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R) Nicotine 2 mg Inactive Ingredients Ingredient Name Strength Acacia (UNII: 5C5403N26O) Acesulfame Potassium (UNII: 23OV73Q5G9) Carnauba Wax (UNII: R12CBM0EIZ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) Magnesium Oxide (UNII: 3A3U0GI71G) Sodium Bicarbonate (UNII: 8MDF5V39QO) Sodium Carbonate (UNII: 45P3261C7T) Sucralose (UNII: 96K6UQ3ZD4) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Xylitol (UNII: VCQ006KQ1E) Product Characteristics Color YELLOW (Light Yellow) Score no score Shape SQUARE Size 14mm Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9805-5 10 in 1 CARTON 10/15/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079044 04/03/2018 Labeler - Lil' Drug Store Products, Inc. (093103646)