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Nicorelief by ATLANTIC BIOLOGICALS CORP.

Dosage form: gum, chewing
Ingredients: NICOTINE 4mg
Labeler: ATLANTIC BIOLOGICALS CORP.
NDC Code: 17856-5734

Major Pharmaceuticals Nicorelief® Drug Facts

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Use
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

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 blood pressure.
stomach ulcer or diabetes

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)

Keep out of reach of children and pets.

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 right away (1-800-222-1222).

Directions
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 your quit day
if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg 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 you hiccups, heartburn, nausea or other side effects.
do not use more than 24 pieces a day
it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information
each piece contains: calcium 100 mg and sodium 11 mg
store at 20-25°C (68-77°F)
protect from light

Inactive ingredients

acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, flavors, gum base, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, talc

Questions or comments?

call 1-866-677-7858

Principal Display Panel

COMPARE TO the active ingredient of NICORETTE® GUM

NEW DIRECTIONS FOR USE

Keep Using if You Slip Up and Have a Cigarette

Use Beyond 12 Weeks if Needed to Quit

NICOrelief®

nicotine polacrilex gum, USP, 4 mg (nicotine)

Stop Smoking Aid

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 NICOrelief®, Nicotine Polacrilex Gum, 2 mg

mint flavor

4mg

50 Pieces

actual size

Includes User’s Guide

Free Audio CD upon request. See inside.

NICORELIEF 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5734(NDC:0904-5737)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN 
ACESULFAME POTASSIUM 
CALCIUM CARBONATE 
CARNAUBA WAX 
D&C YELLOW NO. 10 
SODIUM BICARBONATE 
SODIUM CARBONATE 
SORBITOL 
TALC 
Product Characteristics
ColorYELLOW (light) Scoreno score
ShapeRECTANGLESize16mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:17856-5734-11 GUM, CHEWING in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07832604/12/2005
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIOperations
ATLANTIC BIOLOGICALS CORP.047437707repack(17856-5734), relabel(17856-5734)

Revised: 09/2016
 
ATLANTIC BIOLOGICALS CORP.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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