Adverse reactions reported by 1-2% of 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.
US FDA pregnancy category B. Teratology studies were performed with animals at doses up to two hundred and six hundred times, respectively, the projected human daily dose. No adverse fetal effects were observed. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.
Wash hands immediately after applying Amlexanox oral paste directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.
Pediatric Use: Safety and effectiveness of Amlexanox oral paste in pediatric patients have not been established.
Ingestion of a full tube of 5 grams of paste would result in systemic exposure well below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.
Store in a cool & dry place. Protect from light. Keep out of reach of the children
