NDC 0363-9590 Nicotine
Nicotine Polacrilex Lozenge Oral
What is NDC 0363-9590?
The NDC code 0363-9590 is assigned by the FDA to the UNFINISHED product Nicotine which is a human over the counter drug product labeled by Walgreens. The generic name of Nicotine is nicotine polacrilex. The product's dosage form is lozenge and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 0363-9590-08 4 bottle, plastic in 1 box / 27 lozenge in 1 bottle, plastic, 0363-9590-24 1 bottle, plastic in 1 box / 24 lozenge in 1 bottle, plastic, 0363-9590-27 1 bottle, plastic in 1 box / 27 lozenge in 1 bottle, plastic, 0363-9590-72 3 bottle, plastic in 1 box / 24 lozenge in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Nicotine?
This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.
|Color(s)||WHITE (C48325) |
|Shape||ROUND (C48348) |
|Size(s)||16 MM |
|Flavor(s)||CHERRY (C73375) |
NDC Code 0363-9590-08
Package Description: 4 BOTTLE, PLASTIC in 1 BOX / 27 LOZENGE in 1 BOTTLE, PLASTIC
NDC Code 0363-9590-24
Package Description: 1 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC
NDC Code 0363-9590-27
Package Description: 1 BOTTLE, PLASTIC in 1 BOX / 27 LOZENGE in 1 BOTTLE, PLASTIC
NDC Code 0363-9590-72
Package Description: 3 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC
What are Nicotine Active Ingredients?
- NICOTINE 2 mg/1 - Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.
Nicotine Active Ingredients UNII Codes
- NICOTINE (UNII: 6M3C89ZY6R)
- NICOTINE (UNII: 6M3C89ZY6R) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 359817 - nicotine 2 MG Oral Lozenge
- RxCUI: 359817 - nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge
- RxCUI: 359817 - nicotine 2 MG Troche
Nicotine Inactive Ingredients UNII Codes
- ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MANNITOL (UNII: 3OWL53L36A)
- POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
- POVIDONE (UNII: FZ989GH94E)
- SODIUM ALGINATE (UNII: C269C4G2ZQ)
- SODIUM CARBONATE (UNII: 45P3261C7T)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- XANTHAN GUM (UNII: TTV12P4NEE)
* Please review the disclaimer below.
Nicotine Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH LOZENGE)
- 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.
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Active Ingredient (In Each Lozenge)
Nicotine polacrilex USP, 2 mg
Stop smoking aid
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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, 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 problems occur
- persistent indigestion or severe sore throat occurs
- 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)
Keep Out Of Reach Of Children And Pets.
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
- if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
- before using this product, read the enclosed User’s Guide for complete directions and other important information
- begin using the lozenge on your quit day
- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:
- nicotine lozenge is a medicine and must be used a certain way to get the best results
- place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 to 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
- you may feel a warm or tingling sensation
- occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 to 30 minutes)
- do not eat or drink 15 minutes before using or while the lozenge is in your mouth
- to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
- do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
- do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
- It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.
|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|
- each lozenge contains: sodium 14 mg
- store at 20° to 25°C (68° to 77°F)
- keep bottle tightly closed and protect from light
acesulfame potassium, colloidal silicon dioxide, cherry flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose,xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Nicorette® Lozenge*
NICOTINE POLACRILEX LOZENGE 2mg (NICOTINE)
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 after waking up, use 4 mg Nicotine Polacrilex Lozenge.
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.
3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks.
4. Use With a Support Program as directed in the enclosed User's Guide.
- NOT FOR SALE TO THOSE UNDER 18 YEARS OF AGE
- PROOF OF AGE REQUIRED
- NOT FOR SALE IN VENDING MACHINES OR FROM ANY SOURCE WHERE PROOF OF AGE CANNOT BE VERIFIED
Retain outer carton for full product uses, directions and warnings.
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Lozenge.
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
OPENING DIRECTIONS: PUSH DOWN ON CAP AND TURN TO OPEN
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
WAAALGREENS Nicotine Lozenge Cherry Flavor
* Please review the disclaimer below.