{"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 • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • children under 3 years of age: consult a doctor"],"effective_time":"20220501","id":"4f27a942-b5f3-4a01-8022-49deced585f8","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 right away."],"openfda":{"application_number":["NDA021996"],"brand_name":["Alaway"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Bausch & Lomb Incorporated"],"package_ndc":["24208-601-10","24208-601-95","24208-601-05","24208-601-90"],"product_ndc":["24208-601"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237","707594"],"spl_id":["4f27a942-b5f3-4a01-8022-49deced585f8"],"spl_set_id":["e4c310b5-1dba-4ddc-bc90-b27ebc765871"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel TWIN PACK NDC 24208-601-90 BAUSCH + LOMB Alaway ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Eye Itch Relief UP TO 12 HOURS Works in Minutes Original Prescription Strength For Ages 3 Years And Older 2x 10 mL BOTTLES STERILE 0.34 FL OZ EACH 3842002 AB60192A Carton"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? [Phone icon] Call: 1-800-553-5340"],"set_id":"e4c310b5-1dba-4ddc-bc90-b27ebc765871","spl_product_data_elements":["Alaway 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 a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eyes • itching that worsens or lasts for more than 72 hours"],"version":"15","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 a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eyes • itching that worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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"]}