TERAZOL®7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.

TERAZOL®3 (terconazole) Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.

TERAZOL®3 (terconazole) Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.

The structural formula of terconazole is as follows:

Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.

Last updated on RxList: 4/25/2008

TERAZOL®7 (terconazole) Vaginal Cream 0.4%, TERAZOL®3 (terconazole) Vaginal Cream 0.8% and TERAZOL®3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

TERAZOL®7 (terconazole) Vaginal Cream 0.4%

One full applicator (5 g) of TERAZOL 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.

TERAZOL®3 (terconazole) Vaginal Cream 0.8%

One full applicator (5 g) of TERAZOL 3 Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.

TERAZOL®3 (terconazole) Vaginal Suppositories 80 mg

One TERAZOL 3 Vaginal Suppository (80 mg terconazole) should be administered intra-vaginally once daily at bedtime for three consecutive days.

Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of these products is not affected by menstruation.

TERAZOL®7 (terconazole) Vaginal Cream 0.4% is available in 45g (NDC 0062-5350-01) tubes with an ORTHO* Measured-Dose Applicator. Store at Controlled Room Temperature 15-30°C (59-86°F).

TERAZOL®3 (terconazole) Vaginal Cream 0.8% is available in 20g (NDC 0062-5356-01) tubes with an ORTHO* Measured-Dose Applicator. Store at Controlled Room Temperature 15-30°C (59-86°F).

TERAZOL®3 (terconazole) Vaginal Suppositories 80 mg are available as 2.5g, elliptically-shaped white to off-white suppositories in packages of three (NDC 0062-5351-01) with a vaginal applicator. Store at Controlled Room Temperature 15-30°C (59-86°F).

Manufactured by: Janssen Ortho, LLC Manati, Puerto Rico 00674. Distributed by: ORTHO-McNEIL, PHARMACEUTICAL, INC. Raritan, New Jersey 08869. Revised October 2007. FDA revision date: 6/30/2004

Last updated on RxList: 4/25/2008

TERAZOL®7 (terconazole) Vaginal Cream 0.4%

During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Vulvovaginal burning (5.2%), itching (2.3%) or irritation (3.1%) occurred less frequently with terconazole 0.4% vaginal cream than with the vehicle placebo. Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo) have also been reported. The therapy-related dropout rate was 1.9%. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching (0.6%), which was lower than the incidence for placebo (0.9%).

TERAZOL®3 (terconazole) Vaginal Cream 0.8%

During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole 0.8% vaginal cream 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole 0.8% vaginal cream. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.

TERAZOL®3 (terconazole) Vaginal Suppositories 80 mg

During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with terconazole 80 mg vaginal suppositories. Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole 80 mg vaginal suppositories were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).

TERAZOL®7 (terconazole)Vaginal Cream 0.4% and TERAZOL®3 (terconazole)Vaginal Suppositories 80 mg

The therapeutic effect of these products is not affected by oral contraceptive usage.

TERAZOL®3 (terconazole)Vaginal Cream 0.8%

The levels of estradiol (E2) and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.

Last updated on RxList: 4/25/2008

None.

General: Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.

The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms; therefore concurrent use is not recommended.

Laboratory Tests: If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Studies to determine the carcinogenic potential of terconazole have not been performed.

Mutagenicity: Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.

Impairment of Fertility: No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (25x the recommended intravaginal human dose of the suppository formulation, 50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation, and 100x the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.

Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.

The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream, by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.8% vaginal cream, and by 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 80 mg vaginal suppository. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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.

Pediatric Use

Safety and efficacy in children have not been established.

Geriatric Use

Clinical studies of TERAZOL®did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Last updated on RxList: 4/25/2008

Overdose of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were @ 1280 and ≥ 640 mg/kg, respectively.

Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.

Last updated on RxList: 4/25/2008

Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations.

Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to normal humans, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours.

Results from similar studies in patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy women. The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers.

Following oral (30 mg) administration of ¹⁴C-labelled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47-52%) routes.

In vitro, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.

Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light.

Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream (0.4% and 0.8%).

Microbiology: Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity has also been demonstrated against other fungi. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥ 128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment.

The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability. No resistance to terconazole has developed during successive passages of C. albicans.

Last updated on RxList: 4/25/2008

TERAZOL®7
(terconazole) Vaginal Cream 0.4%

TERAZOL®3
(terconazole) Vaginal Cream 0.8%

Filling the applicator:

1. Remove the cap from the tube.
2. Use the pointed tip on the top of the cap to puncture the seal on the tube.
3. Screw the applicator onto the tube.
4. Squeeze the tube from the bottom and fill the applicator until the plunger stops.
5. Unscrew the applicator from the tube.

Using the applicator:

1. Lie on your back with your knees drawn up toward your chest.
2. Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go.
3. Slowly press the plunger of the applicator to release the cream into the vagina.
4. Remove the applicator from the vagina.
5. Apply one applicatorful each night for as many days at bedtime, as directed by your doctor.

Cleaning the applicator: (Does not apply to sample applicators, which are for one time use only)

After each use, you should thoroughly clean the applicator by following the procedure below:

1. Pull the plunger out of the barrel.
2. Wash the pieces with lukewarm, soapy water, and dry them thoroughly.
3. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

NOTE: Store the cream at Controlled Room Temperature 15-30°C (59-86°F). See end flap for lot number and expiration date.

TERAZOL®3
(terconazole) VAGINAL CREAM 80 mg

Three oval suppositories, for use inside the vagina only.

Designed to be inserted into the vagina.

HOW TO USE:

Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The TERAZOL Suppository is self-lubricating and may be inserted with or without the applicator.

A. Insertion with the applicator

1. Filling the applicator

• Break off suppository from the plastic strip.
• Pull the plastic completely apart at the notched end.
• Place the flat end of the suppository into the open end of the applicator as shown. You are now ready to insert the suppository into the vagina.

2. Using the applicator

• Lie on your back with your knees drawn up toward your chest.
• Holding the applicator by the ribbed end of the barrel, gently insert it into the vagina as far as it will comfortably go.
• Press the plunger to release the suppository into the vagina.
• Remove the applicator from the vagina.

3. Cleaning the applicator (Does not apply to sample applicators, which are for one time use only)

After each use, you should thoroughly clean the applicator by following the procedure below:

• Pull the plunger out of the barrel.
• Wash both pieces with lukewarm, soapy water, and dry them thoroughly.
• Put the applicator back together by gently pushing the plunger into the barrel as far as it will go.

B. Insertion without the applicator

• Lie on your back with your knees drawn up toward your chest.
• Place the suppository on the tip of your finger as shown.
• Insert the suppository gently into the vagina as far as it will comfortably go.

NOTE: Store the suppositories at Controlled Room Temperature 15-30°C (59-86°F). See end flap for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS

Why do yeast infections occur?

Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.

Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

How can I prevent yeast infections?

Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

• Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100% cotton underwear, and stockings may help avoid this problem.
• Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of yeast infections.
• Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.
• Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor.
• Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections.
• Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes may help prevent yeast infection.

Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips:

1. For best results, be sure to use the medication as prescribed by your doctor, even if you feel better quickly.
2. Avoid sexual intercourse, if your doctor advises you to do so. The suppository formulation (not the cream) may damage the diaphragm. Therefore, use of the diaphragm during therapy with the suppository is not recommended. Consult your physician.
3. If your partner has any penile itching, redness, or discomfort, he should consult his physician and mention that you are being treated for a yeast infection.
4. You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medication leaks.
5. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.
6. Wipe from front to rear (away from the vagina) after a bowel movement.
7. Don't douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.
8. Don't scratch if you can help it. Scratching can cause more irritation and spread the infection.
9. Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection.
10. Eat nutritious meals to promote your general health.

Last updated on RxList: 4/25/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

TERCONAZOLE CREAM, SUPPOSITORY - VAGINAL

(ter-KONE-a-zole)

USES: This medication is used to treat vaginal yeast infections. Terconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

If you are pregnant, follow your doctor's instructions on how to use the applicator to insert this medication.

Use the medication once daily, usually at bedtime or as directed by your doctor. Wash your hands before using the medication. If using the cream, use the applicator. If using the suppository, you may use either the applicator or your finger to insert it. Unwrap the suppository before use. Follow the package instructions on how to fill the applicator with the cream or with a suppository. Lie on your back with your knees toward your chest. Insert one applicator full of cream or a suppository into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator all the way down to apply the cream or release the suppository. If you have itching/burning around the outside of the vagina (vulva), you should also apply some cream to that area. Take the applicator apart, wash in lukewarm, soapy water, and dry thoroughly. Wash your hands after use.

Continue to use this medication every day for the full time prescribed, even if symptoms disappear after a few days or if your menstrual period starts. Stopping the medication too soon may allow the yeast infection to return. Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication.

Inform your doctor if your condition persists or returns 1 week after completing the treatment.

SIDE EFFECTS: Headache, body pain, vaginal/urethral burning/itching/pain, or menstrual cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, chills, flu-like symptoms, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using terconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (e.g., clotrimazole, fluconazole); or to vegetable oil; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems, 4 or more vaginal yeast infections per year.

Ask your doctor whether you can have sexual intercourse while using this product. If using the vaginal suppository, avoid using a diaphragm, cervical cap, or latex condoms for birth control while using this product and for 3 days after treatment is finished. Some ingredients in the suppository may damage these products, causing them to possibly break. Use other forms of birth control such as polyurethane condoms.

This medication should not be used during the first 3 months of pregnancy unless your doctor judges that it is necessary. This medication should be used only when clearly needed during the last 6 months of pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral antibiotics, corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., KOH smear, culture) may be performed periodically to monitor your progress. Consult your doctor for more details.

Dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily. This may help to prevent the growth of yeast.

If your sexual partner experiences symptoms, they should contact their doctor immediately.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the cream or suppository at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.