May 26, 2017


(amlexanox) Oral Paste

For Oral Cavity Use Only
Not for Ophthalmic Use


Aphthasol contains 5% amlexanox in an adhesive oral paste. Chemically, amlexanox is 2-amino-7-isopropyl-5-oxo-5H-[1]benzopyrano[2,3-b] pyridine-3-carboxylic acid. It has a molecular formula of C16H14N2O4 and has a molecular weight of 298.30. Amlexanox is odorless, white to yellowish-white crystalline powder. The structural formula is:

 Aphthasol® (amlexanox) Structural Formula Illustration

Each gram of beige colored oral paste contains 50 mg of amlexanox in an adhesive oral paste base consisting of benzyl alcohol, gelatin, glyceryl monostearate, mineral oil, pectin, petrolatum, and sodium carboxymethylcellulose.

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...

Read All Potential Side Effects and See Pictures of Aphthasol »

What are the precautions when taking amlexanox (Aphthasol)?

Before using amlexanox, tell your doctor/dentist or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor/dentist or pharmacist your medical history, especially of: immune system problems.

Avoid alcohol and nicotine because these products can irritate the sores.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Aphthasol »

Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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