Aphthasol contains amlexanox 5% in an adhesive oral paste.

Aphthasol is used to treat canker sores, also called aphthous ulcers, in the mouth in people with normal immune systems.

Aphthasol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aphthasol?

Use Aphthasol as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Less serious side effects are more likely, and you may have none at all. You may feel a slight burning or stinging when you first apply Aphthasol oral paste. Talk to your doctor about any unusual or bothersome side effects.

Use Aphthasol exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

For best results, start using Aphthasol when you first notice symptoms of a canker sore.

Aphthasol oral paste is usually applied 4 times each day--usually after breakfast, lunch, and dinner, and at bedtime.

It is best to apply the paste after you have brushed and rinsed your teeth. Always dry the canker sore with a clean cloth before applying Aphthasol oral paste.

Dry the canker sore with a soft clean cloth before applying the paste.

To use the paste, moisten the tip of your finger with water and squeeze out a 1/4-inch dab of paste onto the wet tip of your finger.

Gently apply the Aphthasol paste to the canker sore. There is no need to rub in the medicine.

Talk with your doctor if your symptoms do not improve after 10 days of treatment.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments. You may not be able to use Aphthasol.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

An overdose of Aphthasol is not likely to cause life-threatening symptoms. Overdose symptoms may include nausea or diarrhea.

There are no restrictions on food, beverages, or activity while using Aphthasol unless your doctor has told you otherwise.

• skin rash;

• new mouth ulcers; or

• white patches or sores inside your mouth or on your lips.

Less serious Aphthasol side effects may include may a slight stinging or burning when you first apply the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.