{"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":"20241113","id":"5fdfe6f1-1210-4349-96e9-68838e2a4330","inactive_ingredient":["Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, and water for injection"],"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":{},"other_safety_information":["Other information ▪ only for use in the eye. ▪ store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]."],"package_label_principal_display_panel":["Principal Display Panel Rugby® NDC 0536-1096-40 Compare to Zaditor® Active ingredient* Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution NEW Formula ANTIHISTAMINE EYE DROPS UP TO 12 HOURS ITCH RELIEF • Works in Minutes • Original Prescription Strength For Ages 3 Years & Older 30 Day Supply 5 mL (0.17 FL OZ) STERILE 0.025% carton"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Write to: Apotex Corp. Consumer Affairs 2400 N. Commerce Pkwy, Suite 400 Weston FL 33326 Or call us at 1-800-706-5575 (Monday to Friday 8:30 am – 5:00 pm Eastern Standard Time)"],"set_id":"82a31fcf-b36d-4111-b2bf-6a51a8b6c5da","spl_product_data_elements":["Eye Itch Relief Ketotifen Fumarate KETOTIFEN FUMARATE KETOTIFEN BENZALKONIUM CHLORIDE GLYCERIN HYDROCHLORIC ACID SODIUM HYDROXIDE WATER"],"spl_unclassified_section":["Drug Facts","*This product Is not manufactured or distributed by Alcon a Novartis Company, distributor of Zaditor®. Manufactured by: Apotex Inc. Toronto, Ontario Canada, M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Made in China TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED, TORN OR BROKEN OR IF THE SEAL AROUND THE PRODUCT LABELED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSING. Rev. 01/19 R-142 Re-order No. 370677"],"spl_unclassified_section_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 01/19</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>R-142</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-order No. 370677</paragraph></td></tr></tbody></table>"],"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 more than 72 hours"],"version":"7","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 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"]}