Tuesday 22 May 2012

Sunmark Nicotine Polacrilex





Dosage Form: gum, chewing
McKesson Nicotine Polacrilex Gum USP, 4 mg (nicotine) Drug Facts

Active ingredient (in each chewing piece)


Nicotine polacrilex (equal to 4 mg nicotine)



Purpose


Stop smoking aid



Uses


  • 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.



Do not use


  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products


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 medication 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 or rapid heartbeat


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.



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

  • stop smoking completely when you begin using the gum

  • if you smoke less than 25 cigarettes a day; use Nicotine Polacrilex Gum, 2 mg

  • if you smoke 25 or more cigarettes a day; use according to the following 12 week schedule:








Weeks 1 to 6Weeks 7 to 9Weeks 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 tingling 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. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor.


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, gelatin, gum base, mannitol, sodium bicarbonate, sodium carbonate, sorbitol, talc, titanium dioxide, xylitol



Questions or comments?


call 1-866-677-7858



Principal Display Panel


Compare to Nicorette® Coated Gum Active Ingredient


Nicotine Polacrilex Gum USP, 4 mg (nicotine)


Stop Smoking Aid


4 mg


Coated Gum


Cool Mint Flavor


For those who smoke 25 or more cigarettes a day


If you smoke less than 25 cigarettes a day: use Nicotine Polacrilex Gum, 2 mg


Actual Size


4 mg Each


Nicotine Polacrilex Gum USP, 4 mg (nicotine) Carton










SUNMARK NICOTINE  POLACRILEX
nicotine  gum, chewing










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)49348-788
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (NICOTINE)NICOTINE4 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorYELLOW (light;coated)Scoreno score
ShapeRECTANGLESize16mm
FlavorMINTImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
149348-788-594 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
110 PARTS In 1 BLISTER PACKThis package is contained within the CARTON (49348-788-59)
249348-788-1010 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
210 PARTS In 1 BLISTER PACKThis package is contained within the CARTON (49348-788-10)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07677912/21/2006


Labeler - McKesson (177667227)
Revised: 07/2009McKesson




More Sunmark Nicotine Polacrilex resources


  • Sunmark Nicotine Polacrilex Side Effects (in more detail)
  • Sunmark Nicotine Polacrilex Dosage
  • Sunmark Nicotine Polacrilex Use in Pregnancy & Breastfeeding
  • Sunmark Nicotine Polacrilex Drug Interactions
  • Sunmark Nicotine Polacrilex Support Group
  • 42 Reviews for Sunmark Nicotine Polacrilex - Add your own review/rating


Compare Sunmark Nicotine Polacrilex with other medications


  • Smoking Cessation

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