{"components":["Active ingredients (in each film) Tadalafil 20 mg – Erectile dysfunction treatment Vardenafil 20 mg – Erectile dysfunction treatment"],"do_not_use":["Do not use if you: take nitrate medicines (such as nitroglycerin) have severe heart disease or very low blood pressure are allergic to tadalafil, vardenafil, or any ingredient in this product have galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption"],"dosage_and_administration":["Dosage and Administration • Take 1 oral film as a single dose. • Administer orally by placing on the tongue until dissolved. • Administer approximately 0.5 to 4 hours prior to anticipated sexual activity. • Do not exceed 1 dose in 24 hours."],"effective_time":"20250902","id":"3dcacd5e-e4fe-5b62-e063-6394a90aaa35","inactive_ingredient":["Inactive ingredients Film-forming polymers, stabilizers, sweeteners, flavoring agents."],"indications_and_usage":["Uses For the treatment of erectile dysfunction (ED)"],"keep_out_of_reach_of_children":["Contraindications Not for use in pregnant or breastfeeding women Not for use in children under 18 years"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 1 2 3 4"],"purpose":["Purpose Phosphodiesterase type 5 (PDE5) inhibitors"],"set_id":"3d70ba63-b543-0c02-e063-6294a90a47fc","spl_product_data_elements":["Esokalli Testosterone Booster Oral Dissolving Film Esokalli Testosterone Booster Oral Dissolving Film TADALAFIL TADALAFIL VARDENAFIL VARDENAFIL HYPROMELLOSES SUCRALOSE SUCROSE"],"stop_use":["Stop use and ask a doctor if: you experience chest pain, fainting, sudden vision or hearing loss an erection lasts longer than 4 hours (priapism). This is a medical emergency."],"version":"4","warnings":["Warnings For adult men only."],"when_using":["When using this product you may experience: headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances"]}