{"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":"20260318","id":"95d70587-2cf2-4e14-8ca3-11b762f1188b","inactive_ingredient":["Inactive ingredients Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH)."],"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":["ANDA077958"],"brand_name":["Ketotifen Fumarate Ophthalmic Solution"],"generic_name":["KETOTIFEN FUMARATE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["72485-617"],"package_ndc":["68788-4084-5"],"product_ndc":["68788-4084"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["95d70587-2cf2-4e14-8ca3-11b762f1188b"],"spl_set_id":["f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"]},"package_label_principal_display_panel":["Packaging Ketotifen Fumarate Ophthalmic Solution 0.035%"],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll-free 1-855-473-6847, weekdays, 7:00 AM - 5:30 PM CT"],"set_id":"f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c","spl_product_data_elements":["Ketotifen Fumarate Ophthalmic Solution Ketotifen Fumarate BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE KETOTIFEN FUMARATE KETOTIFEN"],"spl_unclassified_section":["Drug Facts","Now OTC! ANTIHISTAMINE EYE DROPS UPTO 12 HOURS EYE ITCH RELIEF • Works in Minutes • Original Prescription Strength FOR AGES 3 YEARS AND OLDER 30 DAY SUPPLY Sterile Original Prescription Strength Do not use if seal on bottle is missing or broken. FOR TOPICAL OPHTHALMIC USE ONLY. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA) Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-4084-5"],"storage_and_handling":["Other information • Only for use in the eye. • Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature]."],"version":"2","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 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."]}