{"active_ingredient":["Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)"],"dosage_and_administration":["Directions Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor."],"effective_time":"20090922","id":"2ceef169-7897-9c9a-4ff6-a40018e954f9","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and purified water"],"indications_and_usage":["Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. ZADITOR ketotifen fumarate ophthalmic solution Antihistamine Eye Drops Original Prescription Strength Up to 12 Hour Itch Relief 30 Day Supply Works in Minutes For Ages 3 Years and Older Do not use if seal on bottle is missing or broken. Zaditor 5mL Carton"],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll-free 1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST. Serious side effects associated with the use of this product may be reported to this number."],"set_id":"8a8ae065-07da-4e38-b9d8-9a6937f94f58","spl_product_data_elements":["Zaditor Antihistamine Eye Drops Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN SODIUM HYDROXIDE HYDROCHLORIC ACID WATER"],"spl_unclassified_section":["Other information Only for use in the eye. Store between 4°-25°C (39°-77°F)."],"stop_use":["Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours"],"version":"3","warnings":["Warnings Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation"],"when_using":["When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use"]}