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amlexanox (topical)

Pronunciation: am LEX a nox

Brand: Aphthasol

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

Use this medication 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.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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 amlexanox oral paste. Talk to your doctor about any unusual or bothersome side effects.

What is amlexanox?

Amlexanox is an oral paste that is used to treat canker sores, also called aphthous (AFF-thus) ulcers, in the mouth.

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

What should I discuss with my health care provider before using amlexanox?

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Do not use this medication if you are allergic to amlexanox.

Before using amlexanox, 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 amlexanox.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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It is not known whether amlexanox passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use amlexanox?

Use this medication 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 amlexanox when you first notice symptoms of a canker sore.

Amlexanox 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 amlexanox oral paste.

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Wash your hands before applying amlexanox 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 amlexanox paste to the canker sore. There is no need to rub in the medicine.

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Wash your hands with soap and water to remove any remaining paste from your finger.

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

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Store amlexanox oral paste at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while using amlexanox?

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

What are the possible side effects of amlexanox?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Stop using amlexanox and call your doctor if you have any of these serious side effects:

  • skin rash;
  • new mouth ulcers; or
  • white patches or sores inside your mouth or on your lips.

Less serious 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.

What other drugs will affect amlexanox?

There may be other drugs that can affect amlexanox. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about amlexanox oral paste.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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