Amlexanox (Into the mouth)

How to Store and Dispose of This Medicine

• Store the paste at room temperature, away from heat and moisture. Do not freeze.
• Keep all medicine out of the reach of children.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• If you are pregnant or breastfeeding, talk to your doctor before using this medicine.
• If your symptoms do not get better after using this medicine for 10 days, tell your doctor or dentist.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Increased redness, swelling, or inflammation in your mouth
• Rash

If you notice these less serious side effects, talk with your doctor:

• Temporary stinging, pain, or burning on the areas where the medicine is used

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Amlexanox (am-LEX-a-nox)

Treats canker sores.

Brand Name(s)

Aphthasol

When This Medicine Should Not Be Used

How to Use This Medicine

Paste

• Your doctor or dentist will tell you how much medicine to use and how often.
• Use the medicine on the sores in your mouth.
• Wash your hands with soap and water before and after using this medicine.
• Start using the medicine at the first sign of a canker sore. After that, your doctor may tell you to use the medicine 4 times each day, after breakfast, lunch, dinner, and at bedtime.
• It is best to brush your teeth or rinse your mouth before using the medicine.
• Squeeze about 1/4 inch of paste onto your finger. Gently dab or press the paste on the sore. Cover each sore in your mouth with the medicine.
• Use the paste until your canker sores heals.
• Do not get the medicine in your eyes. If this does happen, rinse your eyes with large amounts of cool water. If you have eye pain or redness that does not go away, tell your doctor.

If a dose is missed:

• Apply the medicine as soon as possible, unless it is almost time for your next dose.
• Skip the missed dose if it is almost time for your next regular dose.
• Do not put on two doses at the same time.