Medications and Drugs

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Brand Names: Aphthasol

Generic Name: amlexanox (topical) (Pronunciation: am LEX a nox)

• What is amlexanox (Aphthasol)?
• What are the possible side effects of amlexanox (Aphthasol)?
• What is the most important information I should know about amlexanox (Aphthasol)?
• What should I discuss with my health care provider before using amlexanox (Aphthasol)?
• How should I use amlexanox (Aphthasol)?
• What happens if I miss a dose (Aphthasol)?
• What happens if I overdose (Aphthasol)?
• What should I avoid while using amlexanox (Aphthasol)?
• What other drugs will affect amlexanox (Aphthasol)?
• Where can I get more information?

What is amlexanox (Aphthasol)?

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 are the possible side effects of amlexanox (Aphthasol)?

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.

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 is the most important information I should know about amlexanox (Aphthasol)?

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.

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.