{"active_ingredient":["Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)"],"dosage_and_administration":["Directions Adults and children 3 years 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":"20230511","how_supplied":["HOW SUPPLIED Product: 50090-6472 NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON"],"id":"9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection"],"indications_and_usage":["Uses For the temporary relief of itchy eyes due to ragweed, pollen, 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 (1-800-222-1222) right away."],"openfda":{"application_number":["NDA021996"],"brand_name":["Ketotifen Fumarate"],"generic_name":["KETOTIFEN FUMARATE"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["0536-1252"],"package_ndc":["50090-6472-0"],"product_ndc":["50090-6472"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["9b869ed6-cd2a-48b5-84b1-c5e0e1f29a89"],"spl_set_id":["1234de19-257c-422c-8706-1239381a2706"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["KETOTIFEN FUMARATE Label Image"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Toll Free Product Information Call: 1-800-645-2158 Distributed by: RUGBY ® LABORATORIES 17177 N Laurel Park Drive Suite 233, Livonia, MI 48152 www.rugbylaboratories.com Product of Italy"],"set_id":"1234de19-257c-422c-8706-1239381a2706","spl_product_data_elements":["Ketotifen Fumarate Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER"],"spl_unclassified_section":["Other Information Store at 4-25°C (39-77°F)"],"stop_use":["Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours"],"version":"1","warnings":["Warnings For external use only Do not use ▪ if you are sensitive to any ingredient in this product ▪ if solution changes color or becomes cloudy ▪ to treat contact lens related irritation When using this product ▪ remove contact lenses before use ▪ wait at least 10 minutes before re-inserting contact lenses after use ▪ do not touch tip of container to any surface to avoid contamination ▪ replace cap after each use Stop use and ask doctor if you experience any of the following: ▪ eye pain ▪ changes in vision ▪ redness of the eyes ▪ itching that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product ▪ remove contact lenses before use ▪ wait at least 10 minutes before re-inserting contact lenses after use ▪ do not touch tip of container to any surface to avoid contamination ▪ replace cap after each use"]}