INDICATIONS AND USAGE Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

WARNINGS Azelastine hydrochloride ophthalmic solution is for ocular use only and not for injection or oral use.

ADVERSE REACTIONS In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%).

The occurrence of these events was generally mild.

The following events were reported in 1 to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring.

Some of these events were similar to the underlying disease being studied.