Oravig is an antifungal medicine that fights infections caused by fungus.

Oravig buccal is a tablet that is placed between your check and gum to treat candida (yeast) infections, such as oral thrush, inside the mouth.

Oravig may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Oravig if you are allergic to miconazole (Monistat, Vusion, and others) or if you are allergic to milk proteins.

To make sure Oravig is safe for you, tell your doctor if you have ever had:

• liver disease; or

• an allergic reaction to antifungal medicine.

It is not known whether Oravig will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether miconazole buccal passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Oravig is not approved for use by anyone younger than 16 years old.

Use Oravig exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of this medicine is one tablet each morning for 14 days in a row.

Brush your teeth before putting in a Oravig buccal tablet. Make sure your hands are dry before handling the tablet.

The Oravig tablet should be placed against your upper gum, just above your incisor tooth. Incisor teeth are located on the right and left sides of your two front teeth.

Place the rounded side of the tablet against your gum. Close your mouth and press your finger gently against the side of your cheek for 30 seconds to make sure the tablet stays in place.

Do not chew or swallow the Oravig buccal tablet. Leave it in place until the next morning. Avoid touching or pressing the tablet while it is in place.

You may eat and drink normally while the tablet is in place, but avoid chewing gum.

During the first 6 hours after placing a buccal tablet in your mouth, if the tablet comes loose try putting it back into place. If the tablet won't stay in place, throw it away and put in a new tablet. If you accidentally swallow a tablet within the first 6 hours of wearing time, drink a full glass of water and put in a new tablet.

After the first 6 hours, if a tablet comes loose or you accidentally swallow it, do not put in a new tablet. Wait until the next morning to put in a new tablet.

If any pieces of the tablet remain in your mouth the next morning, rinse your mouth with water before using a new tablet.

Place the new tablet on the side of your upper gum that is opposite from the side you used the day before. Switch sides of your mouth each morning when using a new tablet.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Oral Thrush:

Oropharyngeal candidiasis: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

Usual Pediatric Dose for Oral Thrush:

Oropharyngeal candidiasis:
16 years or older: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

You should not use Oravig if you are allergic to miconazole (Monistat, Vusion, and others) or if you are allergic to milk proteins.

To make sure Oravig is safe for you, tell your doctor if you have ever had:

• liver disease; or

• an allergic reaction to antifungal medicine.

It is not known whether Oravig will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether miconazole buccal passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Oravig is not approved for use by anyone younger than 16 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid chewing gum, swishing liquid in your mouth, or hitting the tablet while brushing your teeth.

Avoid wearing an upper denture if it gets in the way of the Oravig buccal tablet.

Get emergency medical help if you have signs of an allergic reaction to Oravig hives; trouble swallowing or breathing; swelling of your face, lips, tongue, or throat.

Common Oravig side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea;

• headache; or

• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• phenytoin;

• insulin or oral diabetes medicine;

• a blood thinner - warfarin, Coumadin, Jantoven; or

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine.

This list is not complete. Other drugs may interact with miconazole buccal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.