Label: NICORELIEF- nicotine polacrilex gum, chewing
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-5734-1 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0904-5737
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewing piece)
- Purpose
- Use
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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
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- a sodium-restricted diet
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- heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
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- high blood pressure not controlled with medication. Nicotine can increase blood pressure.
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- stomach ulcer or diabetes
Ask a doctor or pharmacist before use if you are
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- using a non-nicotine stop smoking drug
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- taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Stop use and ask a doctor if
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- mouth, teeth or jaw problems occur
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- irregular heartbeat or palpitations occur
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- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
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- you have symptoms of an allergic reaction (such as difficulty breathing or rash)
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Directions
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- if you are under 18 years of age, ask a doctor before use
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- before using this product, read the enclosed User’s Guide for complete directions and other important information
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- begin using the gum on your quit day
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- if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg
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- 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
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- nicotine gum is a medicine and must be used a certain way to get the best results
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- 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.
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- repeat this process until most of the tingle is gone (about 30 minutes)
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- do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
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- to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
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- 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.
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- do not use more than 24 pieces a day
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- 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
- Inactive ingredients
- Questions or comments?
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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.
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INGREDIENTS AND APPEARANCE
NICORELIEF
nicotine polacrilex gum, chewingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5734(NDC:0904-5737) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg Inactive Ingredients Ingredient Name Strength POLACRILIN (UNII: RCZ785HI7S) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CALCIUM CARBONATE (UNII: H0G9379FGK) CARNAUBA WAX (UNII: R12CBM0EIZ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) SORBITOL (UNII: 506T60A25R) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color YELLOW (light) Score no score Shape RECTANGLE Size 16mm Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-5734-1 1 in 1 POUCH; Type 0: Not a Combination Product 09/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078326 04/12/2005 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-5734) , relabel(17856-5734)