CHANTIX™
(varenicline) Tablets

CHANTIX™ tablets contain the active ingredient, varenicline (as the tartrate salt), which is a partial agonist selective for α₄β₂ nicotinic acetylcholine receptor subtypes.

Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C₁₃H₁₃N₃• C₄H₆O₆. The chemical structure is:

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: 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.

Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors. The efficacy of CHANTIX in smoking cessation is believed to be the result of varenicline's activity at a sub-type of the nicotinic receptor where its binding produces agonist activity, while simultaneously preventing nicotine binding to α4β2 receptors.

Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine. Varenicline blocks the ability of nicotine to activate α4β2 receptors and thus to stimulate the central nervous mesolimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking. Varenicline is highly selective and binds more potently to α4β2 receptors than to other common nicotinic receptors (>500-fold α3β4, >3500-foldα7, >20,000-fold α1βγδ), or to non-nicotinic receptors and transporters (>2000-fold). Varenicline also binds with moderate affinity (Ki = 350 nM) to the 5-HT3 receptor.

Drug interaction studies were performed with varenicline and digoxin, warfarin, transdermal nicotine, bupropion, cimetidine and metformin. No clinically meaningful pharmacokinetic drug-drug interactions have been identified.

In vitro studies demonstrated that varenicline does not inhibit the following cytochrome P450 enzymes (IC50 >6400 ng/mL): 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5. Also, in human hepatocytes in vitro, varenicline does not induce the cytochrome P450 enzymes 1A2 and 3A4.

In vitro studies demonstrated that varenicline does not inhibit human renal transport proteins at therapeutic concentrations. Therefore, drugs that are cleared by renal secretion (e.g. metformin - see below) are unlikely to be affected by varenicline.

In vitro studies demonstrated the active renal secretion of varenicline is mediated by the human organic cation transporter, OCT2. Co-administration with inhibitors of OCT2 may not require a dose adjustment of CHANTIX as the increase in systemic exposure to CHANTIX is not expected to be clinically meaningful (see Cimetidine interaction below). Furthermore, since metabolism of varenicline represents less than 10% of its clearance, drugs known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of CHANTIX (see Pharmacokinetics) and therefore a dose adjustment of CHANTIX would not be required.

The efficacy of CHANTIX in smoking cessation was demonstrated in six clinical trials in which a total of 3659 chronic cigarette smokers (≥10 cigarettes per day) were treated with CHANTIX. In all clinical studies, abstinence from smoking was determined by patient self-report and verified by measurement of exhaled carbon monoxide (CO≤10 ppm) at weekly visits. Among the CHANTIX treated patients enrolled in these studies, the completion rate was 65%. Except for the initial Phase 2 study (Study 1) and the maintenance of abstinence study (Study 6), patients were treated for 12 weeks and then were followed for 40 weeks post-treatment. Most subjects enrolled in these trials were white (79%– 96%). All studies enrolled almost equal numbers of men and women. The average age of subjects in these studies was 43 years. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years.

In all studies, patients were provided with an educational booklet on smoking cessation and received up to 10 minutes of smoking cessation counseling at each weekly treatment visit according to Agency for Healthcare Research and Quality guidelines. Patients set a date to stop smoking (target quit date, TQD) with dosing starting 1 week before this date.

These identical double-blind studies compared CHANTIX 2 mg per day, bupropion sustained release (SR) 150 mg BID, and placebo. Patients were treated for 12 weeks and then were followed for 40 weeks post-treatment. The CHANTIX dosage of 1 mg BID was achieved using a titration of 0.5 mg QD for the initial 3 days followed by 0.5 mg BID for the next 4 days. The bupropion SR dosage of 150 mg BID was achieved using a 3-day titration of 150 mg QD. Study 4 enrolled 1022 subjects and Study 5 enrolled 1023 subjects. Patients inappropriate for bupropion treatment or patients who had previously used bupropion were excluded.

In Study 4, subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (44%) compared to patients treated with bupropion SR (30%) or placebo (17%). The bupropion SR quit rate was also superior to placebo. In addition, 29% of the CHANTIX group were continuously abstinent from one week after TQD through the end of treatment as compared to 12% of the placebo group and 23% of the bupropion SR group.

Similarly in Study 5, subjects treated with CHANTIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 (44%) compared to patients treated with bupropion SR (30%) or placebo (18%). The bupropion SR quit rate was also superior to placebo. In addition, 29% of the CHANTIX group were continuously abstinent from one week after TQD through the end of treatment as compared to 11% of the placebo group and 21% of the bupropion SR group.

Figure 1: Continuous Abstinence, Weeks 9 through 12

Based on responses to the Brief Questionnaire of Smoking Urges and the Minnesota Nicotine Withdrawal scale "Urge to Smoke" li, CHANTIX reduced urge to smoke compared to placebo in all studies.

Studies 1 through 5 included 40 weeks of post-treatment follow-up. In each study, CHANTIX treated patients were more likely to maintain abstinence throughout the follow-up period than were patients treated with placebo (Figure 2, Table 2).

Figure 2: Continuous Abstinence, Weeks 9 through 52

This study assessed the effect of an additional 12 weeks of CHANTIX therapy on the likelihood of long-term abstinence. Patients in this study (n=1927) were treated with open-label CHANTIX 1 mg BID for 12 weeks. Patients who had stopped smoking by Week 12 were then randomized to double-blind treatment with CHANTIX (1 mg BID) or placebo for an additional 12 weeks and then followed for 28 weeks post-treatment.

The continuous abstinence rate from Week 13 through Week 24 was higher for subjects continuing treatment with CHANTIX (70%) than for subjects switching to placebo (50%). Superiority to placebo was also maintained during 28 weeks post-treatment follow-up (CHANTIX 54% versus placebo 39%).

In Figure 3 below, the x-axis represents the study week for each observation allowing a comparison of groups at similar times after discontinuation of CHANTIX. Post-CHANTIX follow-up begins at Week 13 for the placebo group and Week 25 for the CHANTIX group. The y-axis represents the percent of subjects who had been abstinent for the last week of CHANTIX treatment and remained abstinent at the given timepoint.

Figure 3: Continuous Abstinence Rate during nontreatment follow-up

CHAMPIX is indicated as an aid to smoking cessation treatment.

Nausea was the most common adverse event associated with CHANTIX treatment. Nausea was generally described as mild or moderate and often transient; however, for some subjects, it was persistent over several months. The incidence of nausea was dose-dependent. Initial dose-titration was beneficial in reducing the occurrence of nausea. Nausea was reported by approximately 30% of patients treated with CHANTIX 1 mg BID after an initial week of dose titration. In patients taking CHANTIX 0.5 mg BID, the incidence of nausea was 16% following initial titration. Approximately 3% of subjects treated with CHANTIX 1 mg BID in studies involving 12 weeks of treatment discontinued treatment prematurely because of nausea. For patients with intolerable nausea, dose reduction should be considered.

Based on varenicline characteristics and clinical experience to date, CHANTIX has no clinically meaningful pharmacokinetic drug interactions (See CLINICAL PHARMACOLOGY, Drug- Drug Interactions).

Varenicline succinate has been shown to have an adverse effect on the fetus in animal reproduction studies. Administration of varenicline succinate to pregnant rabbits resulted in reduced fetal weights at an oral dose of 30 mg/kg/day (50 times the human AUC at 1 mg BID); this reduction was not evident following treatment with 10 mg/kg/day (23 times the maximum recommended daily human exposure based on AUC). In addition, in the offspring of pregnant rats treated with varenicline succinate there were decreases in fertility and increases in auditory startle response at an oral dose of 15 mg/kg/day (36 times the maximum recommended human daily exposure based on AUC at 1 mg BID).

There are no adequate and well-controlled studies in pregnant women. CHANTIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Although it is not known whether this drug is excreted in human milk, animal studies have demonstrated that varenicline can be transferred to nursing pups. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from CHANTIX, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The potential effects of CHANTIX on labor and delivery are not known.

Safety and effectiveness of CHANTIX in pediatric patients have not been established; therefore, CHANTIX is not recommended for use in patients under 18 years of age.

A combined single and multiple-dose pharmacokinetic study demonstrated that the pharmacokinetics of 1 mg varenicline given QD or BID to 16 healthy elderly male and female smokers (aged 65-75 yrs) for 7 consecutive days was similar to that of younger subjects. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION, Special Populations, Patients with impaired renal function).

No dosage adjustment is recommended for elderly patients (see DOSAGE AND ADMINISTRATION, Special Populations).

• Patients should be instructed to set a date to quit smoking and to initiate CHANTIX treatment one week before the quit date.
• Patients should be advised that CHANTIX should be taken after eating, and with a full glass of water.
• Patients should be instructed how to titrate CHANTIX, beginning at a dose of 0.5 mg/day. Prescribers should explain that one 0.5 mg tablet should be taken daily for the first three days, and that for the next four days, one 0.5 mg tablet should be taken in the morning and one 0.5 mg tablet should be taken in the evening.
• Patients should be advised that, after the first seven days, the dose should be increased to one 1 mg tablet in the morning and one 1 mg tablet in the evening.
• Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.
• Patients should be informed that nausea and insomnia are side effects of CHANTIX and are usually transient; however, patients should be advised that if they are persistently troubled by these symptoms, they should notify the prescribing physician so that a dose reduction can be considered.
• Patients should also be provided with educational materials and necessary counseling to support an attempt at quitting smoking.
• Patients should be informed that some medications may require dose adjustment after quitting smoking.
• Patients intending to become pregnant or planning to breast-feed an infant should be advised of the risks of smoking and risks and benefits of smoking cessation with CHANTIX.
• Patients should be advised to use caution driving or operating machinery until they know how quitting smoking and/or varenicline may affect them.

During the premarketing development of CHANTIX, over 4500 individuals were exposed to CHANTIX, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less.

In Phase 2 and 3 placebo-controlled studies, the treatment discontinuation rate due to adverse events in patients dosed with 1 mg BID was 12% for CHANTIX compared to 10% for placebo in studies of three months' treatment. In this group, the discontinuation rates for the most common adverse events in CHANTIX treated patients were as follows: nausea (3% vs. 0.5% for placebo), headache (0.6% vs. 0.9% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo).

Adverse Events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1).

The most common adverse events associated with CHANTIX (>5% and twice the rate seen in placebo-treated patients) were nausea, sleep disturbance, constipation, flatulence, and vomiting.

Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.

The most common adverse event associated with CHANTIX treatment is nausea. For patients treated to the maximum recommended dose of 1 mg BID following initial dosage titration, the incidence of nausea was 30% compared with 10% in patients taking a comparable placebo regimen. In patients taking CHANTIX 0.5 mg BID following initial titration, the incidence was 16% compared with 11% for placebo. Nausea was generally described as mild or moderate and often transient; however, for some subjects, it was persistent throughout the treatment period.

Table 3 shows the adverse events for CHANTIX and placebo in the 12 week fixed dose studies with titration in the first week (Studies 2 (titrated arm only), 4, and 5). MedDRA High Level Group Terms (HLGT) reported in ≥ 5% of patients in the CHANTIX 1 mg BID dose group, and more commonly than in the placebo group, are uled, along with subordinate Preferred Terms (PT) reported in ≥ 1% of CHANTIX patients (and at least 0.5% more frequent than placebo). Closely related Preferred Terms such as 'Insomnia', 'Initial insomnia', 'Middle insomnia', 'Early morning awakening' were grouped, but individual patients reporting two or more grouped events are only counted once.

The overall pattern, and the frequency of adverse events during the longer-term trials was very similar to that described in Table 3, though several of the most common events were reported by a greater proportion of patients. Nausea, for instance, was reported in 40% of patients treated with CHANTIX 1 mg BID in a one-year study, compared to 8% of placebo-treated patients.

Following is a ul of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The uling does not include those events already uled in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

BLOOD AND LYMPHATIC SYSTEM DISORDERS. Infrequent: Anemia, Lymphadenopathy. Rare: Leukocytosis, Thrombocytopenia, Splenomegaly.

CARDIAC DISORDERS. Infrequent: Angina pectoris, Arrhythmia, Bradycardia, Ventricular extrasystoles, Myocardial infarction, Palpitations, Tachycardia. Rare: Atrial fibrillation, Cardiac flutter, Coronary artery disease, Cor pulmonale, Acute coronary syndrome.

EAR AND LABYRINTH DISORDERS. Infrequent: Tinnitus, Vertigo. Rare: Deafness, Meniere's disease.

ENDOCRINE DISORDERS. Infrequent: Thyroid gland disorders.

EYE DISORDERS. Infrequent: Conjunctivitis, Dry eye, Eye irritation, Vision blurred, Visual disturbance, Eye pain. Rare: Acquired night blindness, Blindness transient, Cataract subcapsular, Ocular vascular disorder, Photophobia, Vitreous floaters.

GASTROINTESTINAL DISORDERS. Frequent: Diarrhea, Gingivitis. Infrequent: Dysphagia, Enterocolitis, Eructation, Gastritis, Gastrointestinal hemorrhage, Mouth ulceration, Esophagitis. Rare: Gastric ulcer, Intestinal obstruction, Pancreatitis acute.

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS. Frequent: Chest pain, Influenza like illness, Edema, Thirst. Infrequent: Chest discomfort, Chills, Pyrexia.

HEPATOBILIARY DISORDERS. Infrequent: Gall bladder disorder.

IMMUNE SYSTEM DISORDERS. Infrequent: Hypersensitivity. Rare: Drug hypersensitivity.

INVESTIGATIONS. Frequent: Liver function test abnormal, Weight increased. Infrequent: Electrocardiogram abnormal, Muscle enzyme increased, Urine analysis abnormal.

METABOLISM AND NUTRITION DISORDERS. Infrequent: Diabetes mellitus, Hyperlipidemia, Hypokalemia. Rare: Hyperkalemia, Hypoglycemia.

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS. Frequent: Arthralgia, Back pain, Muscle cramp, Musculoskeletal pain, Myalgia. Infrequent: Arthritis, Osteoporosis. Rare: Myositis.

NERVOUS SYSTEM DISORDERS. Frequent: Disturbance in attention, Dizziness, Sensory disturbance. Infrequent: Amnesia, Migraine, Parosmia, Psychomotor hyperactivity, Restless legs syndrome, Syncope, Tremor. Rare: Balance disorder, Cerebrovascular accident, Convulsion, Dysarthria, Facial palsy, Mental impairment, Multiple sclerosis, Nystagmus, Psychomotor skills impaired, Transient ischemic attack, Visual field defect.

PSYCHIATRIC DISORDERS. Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. Infrequent: Aggression, Agitation, Disorientation, Dissociation, Libido decreased, Mood swings, Thinking abnormal. Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation.

RENAL AND URINARY DISORDERS. Frequent: Polyuria. Infrequent: Nephrolithiasis, Nocturia, Urine abnormality, Urethral syndrome. Rare: Renal failure acute, Urinary retention.

REPRODUCTIVE SYSTEM AND BREAST DISORDERS. Frequent: Menstrual disorder. Infrequent: Erectile dysfunction. Rare: Sexual dysfunction.

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS. Frequent: Epistaxis, Respiratory disorders. Infrequent: Asthma. Rare: Pleurisy, Pulmonary embolism.

SKIN AND SUBCUTANEOUS TISSUE DISORDERS. Frequent: Hyperhidrosis. Infrequent: Acne, Dermatitis, Dry skin, Eczema, Erythema, Psoriasis, Urticaria. Rare: Photosensitivity reaction.

VASCULAR DISORDERS. Frequent: Hot flush, Hypertension. Infrequent: Hypotension, Peripheral ischemia, Thrombosis.

Varenicline is not a controlled substance.

In case of overdose, standard supportive measures should be instituted as required.

Varenicline has been shown to be dialyzed in patients with end stage renal disease (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Pharmacokinetics in Special Patient Populations), however, there is no experience in dialysis following overdose.

Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Patients should be provided with appropriate educational materials and counseling to support the quit attempt.

The patient should set a date to stop smoking. CHANTIX dosing should start one week before this date.

CHANTIX should be taken after eating and with a full glass of water.

The recommended dose of CHANTIX is 1 mg twice daily following a 1-week titration as follows:

Patients who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.

Patients should be treated with CHANTIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHANTIX is recommended to further increase the likelihood of long-term abstinence.

Patients who do not succeed in stopping smoking during 12 weeks of initial therapy, or who relapse after treatment, should be encouraged to make another attempt once factors contributing to the failed attempt have been identified and addressed.

CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. CHANTIX is supplied in the following package configurations:

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) (see USP Controlled Room Temperature).

Read the patient information that comes with CHANTIX before you start taking it and each time you get a refill.  There may be new information. This information does not take the place of talking with your doctor about your condition or treatment.

WHAT IS CHANTIX?

CHANTIX is a prescription medicine to help adults stop smoking.

WHO SHOULD NOT TAKE CHANTIX?

CHANTIX has not been studied in children under 18 years of age. CHANTIX is not recommended for children under 18 years of age.

Do not take CHANTIX if you are allergic to anything in it. See a complete ul of ingredients at the end of this leaflet.

WHAT SHOULD I TELL MY DOCTOR BEFORE STARTING CHANTIX?

Tell your doctor about all of your medical conditions including if you:

• have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of CHANTIX for you.
• are pregnant or plan to become pregnant. CHANTIX has not been studied in pregnant women. It is not known if CHANTIX will harm your unborn baby. It is best to stop smoking before you get pregnant.
• are breastfeeding. Although it was not studied, CHANTIX may pass into breast milk. You and your doctor should discuss alternative ways to feed your baby if you take CHANTIX.

Tell your doctor about all your other medicines including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take:

• insulin
• asthma medicines
• blood thinners.

When you stop smoking, there may be a change in how these and other medicines work for you.

Know the medicines you take. Keep a ul of them with you to show your doctor and pharmacist.

HOW DO I TAKE CHANTIX?

• Choose a quit date when you will stop smoking.
• Start taking CHANTIX 1 week (7 days) before your quit 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 your quit date. If you slip, try again. Some people need a few weeks for CHANTIX to work best.
• Take CHANTIX after eating and with a full glass (8 ounces) of water.
• Most people will keep taking CHANTIX for up to 12 weeks. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of CHANTIX may 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. See the chart below for dosing instructions.

• This dosing schedule may not be right for everyone. Talk to your doctor if you are having side effects such as nausea or sleep problems. Your doctor may want to reduce your dose.
• If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, wait. Just take your next regular dose.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF CHANTIX?

The most common side effects of CHANTIX include:

• nausea
• sleep disturbance (trouble sleeping, changes in dreaming)
• constipation
• gas
• vomiting

Tell your doctor about side effects that bother you or that do not go away.

These are not all the side effects of CHANTIX. Ask your doctor or pharmacist for more information.

Use caution driving or operating machinery until you know how quitting smoking and/or using CHANTIX may affect you.

HOW SHOULD I STORE CHANTIX?

• 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 conditions other than those described in patient information leaflets. Do not use CHANTIX for a condition for which it was not prescribed. Do not give your CHANTIX to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet 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.

To find out more about CHANTIX and tips on how to quit smoking:

• Go to the CHANTIX website at www.CHANTIX.com.
• Call 1-877-CHANTIX (877-242-6849).

WHAT IS IN CHANTIX?

Active ingredient: varenicline tartrate

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