Aphthasol is indicated for the treatment of aphthous ulcers in people with normal immune systems. It is indicated for individuals 18 years or older.

Safety and effectiveness of Aphthasol (amlexanox oral paste), 5% in pediatric patients have not been established

Clinical Studies of Aphthasol did not include sufficient numbers of subjects aged 54 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Aphthasol (amlexanox oral paste), 5%, is contraindicated in patients with known hypersensivity to amlexanox or other ingredients in the formulation

Safety and effectiveness of amlexanox in immunocompromised patient have not been assessed!

Adverse Reactions considered related or possibly related to amlexanox oral paste, 5%, were not reported by more than 5% of patients. Adverse reactions reported by 1-2% of the patients were transient pain stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea

There are no reports of human ingestion overdosage. Ingestion of a full tube of 5 grams of paste would result in systematic exposure well below the maximum nontoxic dose of amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.