Aphthasol

Generic name: Amlexanox (topical)
Drug class: Mouth and throat products

Usage of Aphthasol

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.

Aphthasol side effects

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 Aphthasol 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 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.

    Before taking Aphthasol

    Do not use Aphthasol if you are allergic to amlexanox.

    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.

    FDA pregnancy category B. Aphthasol is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether amlexanox passes into breast milk or if it could harm a nursing baby. Do not use Aphthasol without telling your doctor if you are breast-feeding a baby.

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    How to use Aphthasol

    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.

    Wash your hands before applying the 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.

    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.

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

    What other drugs will affect Aphthasol

    There may be other drugs that can affect Aphthasol. 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.

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