Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Antihistamine
"],"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":"20231215","id":"bed738a0-2943-46e7-a65e-2440dac7971b","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerol, purified water, 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":["ANDA077200"],"brand_name":["Zaditor"],"generic_name":["KETOTIFEN FUMARATE"],"is_original_packager":[true],"manufacturer_name":["Alcon Laboratories, Inc."],"package_ndc":["0065-4011-05","0065-4011-06","0065-4011-11"],"product_ndc":["0065-4011"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["284380","311237"],"spl_id":["bed738a0-2943-46e7-a65e-2440dac7971b"],"spl_set_id":["ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f"],"substance_name":["KETOTIFEN FUMARATE"],"unii":["HBD503WORO"],"upc":["0300654011057"]},"other_safety_information":["Other information Only for use in the eye. Store between 4°-25°C (39°-77°F)."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF Works in minutes Original prescription strength For ages 3 years and older up to 12 HOURS Alcon STERILE 30 DAY SUPPLY 5mL (0.17 FL OZ) Systane® ZADITOR® Original Prescription Strength Up to 12 Hour Itch Relief Works in Minutes For Ages 3 Years and Older 30 DAY SUPPLY TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Country of Origin: Italy 300048650-0821 ACTUAL SIZE LOT: EXP.: Systane ® ZADITOR ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS EYE ITCH RELIEF 5mL (0.17 FL OZ) STERILE Only for use in the eye. Store between 4° - 25°C (39° - 77°F). TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. Manufactured by: Alcon Laboratories, Inc. 6201 South Freeway, Fort Worth, TX 76134 H15433-1018"],"purpose":["Active ingredient Purpose Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Antihistamine"],"purpose_table":["
Active ingredient
Purpose
Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Antihistamine
"],"questions":["Questions? In the US, call toll-free 1-800-757-919 5 alcon.medinfo@alcon.com www.systane.com Serious side effects associated with use of this product may be reported to this number."],"set_id":"ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f","spl_product_data_elements":["Zaditor ketotifen fumarate Ketotifen Fumarate Ketotifen Benzalkonium Chloride Glycerin Sodium Hydroxide Hydrochloric Acid Water Zaditor Carton bottle label"],"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":"13","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":["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"]}