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Generic Name: amlexanox (am-LEX-an-ox)
Brand Name: Aphthasol

Aphthasol is used for:

Treating canker sores.

Aphthasol is an anti-inflammatory agent. How amlexanox works is not fully known. It appears to stop inflammatory reactions (eg, pain, redness, swelling) and allow sores to heal.

Do NOT use Aphthasol if:

  • you are allergic to any ingredient in Aphthasol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aphthasol:

Some medical conditions may interact with Aphthasol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a weakened immune system

Some MEDICINES MAY INTERACT with Aphthasol. Because little, if any, of Aphthasol is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aphthasol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aphthasol:

Use Aphthasol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Apply Aphthasol after oral hygiene after breakfast, lunch, dinner, and at bedtime unless otherwise directed by your doctor.
  • Apply the paste as soon as possible after noticing the symptoms of canker sores.
  • Dry the ulcers by gently patting with a soft, clean cloth.
  • Wash your hands before and immediately after applying Aphthasol.
  • Moisten the tip of your index finger. Squeeze a dab of paste approximately one-fourth of an inch onto your fingertip. Dab paste onto each ulcer in the mouth using gentle pressure.
  • Use the paste until the ulcer heals. If significant healing or pain reduction has not occurred within 10 days, consult your dentist or doctor.
  • If you miss a dose of Aphthasol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Aphthasol.

Important safety information:

  • Avoid getting Aphthasol in your eyes. Wash eyes promptly if paste gets into eyes.
  • Use Aphthasol with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Aphthasol, discuss with your doctor the benefits and risks of using Aphthasol during pregnancy. It is unknown if Aphthasol is excreted in breast milk. If you are or will be breast feeding while you are using Aphthasol, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Aphthasol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Short-term pain, stinging, or burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); inflammation of the lining of the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; vomiting.

Proper storage of Aphthasol:

Store Aphthasol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aphthasol out of the reach of children and away from pets.

General information:

  • If you have any questions about Aphthasol, please talk with your doctor, pharmacist, or other health care provider.
  • Aphthasol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aphthasol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aphthasol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aphthasol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aphthasol.

Issue Date: June 3, 2015