{"active_ingredient":["Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)"],"do_not_use":["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"],"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 to 12 hours, no more than twice per day. • Children under 3 years of age: Consult a doctor."],"effective_time":"20260515","id":"45477f1c-fa33-4ecc-b608-67280f68385a","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid."],"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":{"application_number":["ANDA204059"],"brand_name":["Ketotifen Fumarate"],"generic_name":["KETOTIFEN FUMARATE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["76385-106"],"package_ndc":["68788-8715-5"],"product_ndc":["68788-8715"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["45477f1c-fa33-4ecc-b608-67280f68385a"],"spl_set_id":["5196ec5b-42d9-40db-a77a-c00360b8cee6"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["Principal Display Panel - Bottle Carton NDC 68788-8715-5 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile Ketotifen Fumarate Ophthalmic Solution 0.035%"],"purpose":["Purpose Antihistamine"],"questions":["Questions? Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number. Code No.: GO/DRUGS/557 Manufactured For: Bayshore Pharmaceuticals LLC., Short Hills, NJ 07078 Made in India. Relabeled By: Preferred Pharmaceuticals Inc."],"set_id":"5196ec5b-42d9-40db-a77a-c00360b8cee6","spl_product_data_elements":["Ketotifen Fumarate Ketotifen Fumarate KETOTIFEN FUMARATE Ketotifen GLYCERIN SODIUM HYDROXIDE HYDROCHLORIC ACID BENZALKONIUM CHLORIDE"],"spl_unclassified_section":["Other information • Only for use in the eye. • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]."],"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 For external use only 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 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 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 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 • 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"]}