In the U.S.—

• Antiulcer agent (topical)

Amlexanox ( am-LEX-an-ox) is used as a paste in the mouth to treat aphthous ulcers (canker sores).

APHTHASOL is available only with your doctor's prescription, in the following dosage form:

Mucosal-Local
• Oral paste (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amlexanox, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amlexanox. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Amlexanox has not been studied in humans. However, studies in animals have not found that it causes any birth defects or other problems.

Breast-feeding—It is not known whether amlexanox passes into breast milk in humans. However, it does pass into the milk in lactating animals. Although most medicines pass into human breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking APHTHASOL and who wish to breast-feed should discuss this with their doctor.

Children—There is no specific information comparing use of amlexanox in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of amlexanox in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Immune system problems—It is not known if APHTHASOL will work properly in patients with these problems

How to use APHTHASOL:

• Apply APHTHASOL to the canker sore as soon as you notice it.
• Squeeze a small amount of the paste (about 1/4 inch) onto your fingertip. Using gentle pressure, dab the paste onto each sore in your mouth.
• Wash your hands immediately after using amlexanox paste.
• Keep using the medicine until the sore is healed. However, if it is not healed after 10 days, check with your doctor.
• Do not get any of the paste in your eyes. If any gets in your eyes, wash them out with water right away.

Dosing—

The dose of amlexanox paste may be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of amlexanox. If your dose is different, do not change it unless your doctor tells you to do so.

• For mucosal-local dosage form (oral paste):
  • For treatment of canker sores:
    • Adults—Apply to each canker sore in the mouth four times a day, after you brush your teeth after breakfast, lunch, dinner, and at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of APHTHASOL, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

To store APHTHASOL:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.