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CHANTIX- varenicline tartrate tablet, film coated


  1. Patient Information
  2. If You, Your Family, Or Caregiver Notice Agitation, Hostility, Depression Or Changes In Behavior Or Thinking That Are Not Typical For You, Or You Develop Any Of The Following Symptoms, Stop Taking Chantix And Call Your Healthcare Provider Right Away:
  3. Do Not Take Chantix If You Have Had A Serious Allergic Or Skin Reaction To Chantix, Which May Include:
  4. Before You Take Chantix, Tell Your Doctor If You:
  5. What Are The Possible Side Effects Of Chantix?
  6. What Are The Ingredients In Chantix?
  7. Inactive Ingredients:
  8. Repackaged By:
  9. Revised: 9/2010document Id:

Patient Information 

Some people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment, or after stopping CHANTIX.

If You, Your Family, Or Caregiver Notice Agitation, Hostility, Depression Or Changes In Behavior Or Thinking That Are Not Typical For You, Or You Develop Any Of The Following Symptoms, Stop Taking Chantix And Call Your Healthcare Provider Right Away: 

  • thoughts about suicide or dying, or attempts to commit suicide
  • new or worse depression, anxiety, or panic attacks
  • feeling very agitated or restless
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • abnormal thoughts or sensations
  • CHANTIX is a prescription medicine to help adults stop smoking.

    Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking.

    CHANTIX is not recommended for people under 18 years of age.

    CHANTIX has not been studied with other treatments for stopping smoking.

Do Not Take Chantix If You Have Had A Serious Allergic Or Skin Reaction To Chantix, Which May Include: 

  • swelling of the face, mouth, and throat that can cause trouble breathing.
  • rash, swelling, redness, and peeling of the skin.

Before You Take Chantix, Tell Your Doctor If You: 

  • have ever had depression or other mental health problems.

    • Take CHANTIX exactly as prescribed by your doctor.
      1. Choose aquit datewhen you will stop smoking.
      2. Start taking CHANTIX 1 week (7 days) before yourquit date. This lets CHANTIX build up in your body. You can keep smoking during this time. Make sure that you try and stop smoking on yourquit date. If you slip-up and smoke, try again. Some people need to take CHANTIX for a few weeks for CHANTIX to work best.
      3. Take CHANTIX after eating and with a full glass (8 ounces) of water.
      4. Most people will take CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, your doctor may prescribe CHANTIX for another 12 weeks to help you stay cigarette-free.
    • CHANTIX comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet.

      Use caution driving or operating machinery until you know how CHANTIX may affect you. Some people who use CHANTIX may feel sleepy, dizzy, or have trouble concentrating, that can make it hard to drive or perform other activities safely.

What Are The Possible Side Effects Of Chantix? 

  • Some patients have had new or worse mental health problems.

    • Store CHANTIX at room temperature, 59 to 86 F (15 to 30 C).
    • Safely dispose of CHANTIX that is out of date or no longer needed.
    • Keep CHANTIX and all medicines out of the reach of children.

    General information about CHANTIX

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not useCHANTIXfor a condition for which it was not prescribed. Do not give yourCHANTIXto other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about CHANTIX. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about CHANTIX that is written for healthcare professionals.

    For more about CHANTIX and tips on how to quit smoking, go towww.CHANTIX.comor call1-877-CHANTIX (877-242-6849).

What Are The Ingredients In Chantix? 

Active ingredient: varenicline tartrate

Inactive Ingredients: 

microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry White (for 0.5 mg), Opadry Blue (for 1 mg), and Opadry Clear (for both 0.5 mg and 1 mg)

Rx only

Company Logo

LAB-0328-9.0

April 2010

Repackaged By: 

Rebel Distributors Corp

Thousand Oaks, CA 91320

Chantix 0.5mg
CHANTIX
varenicline tartrate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21695-633(NDC:0069-0468)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
varenicline tartrate(UNII: 82269ASB48) (varenicline - UNII:W6HS99O8ZO)varenicline0.5 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline(UNII: OP1R32D61U)
anhydrous dibasic calcium phosphate(UNII: L11K75P92J)
croscarmellose sodium(UNII: M28OL1HH48)
silicon dioxide(UNII: ETJ7Z6XBU4)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Capsular)Size8mm
FlavorImprint CodePfizer;CHX;0;5
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-633-5656 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192805/10/2006
Labeler -Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 9/2010document Id: 

f990eca6-fe6f-4423-a118-4b7b970995a1Set id: f990eca6-fe6f-4423-a118-4b7b970995a1Version: 1Effective Time: 20100923Rebel Distributors Corp



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