Active Ingredients (In Each Film)
Tadalafil 30 mg – Erectile dysfunction treatment
Vardenafil 10 mg – Erectile dysfunction treatment
Esokalli Testosterone Booster Oral Dissolving Film Film, Soluble
FDA Label NDC 84778-089
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yixin Cross-border E-commerce Co., Ltd. for the product Esokalli Testosterone Booster Oral Dissolving Film (NDC 84778-089). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each film), purpose, uses, warnings, do not use if you:, dosage and administration, when using this product you may experience:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Phosphodiesterase type 5 (PDE5) inhibitors
Uses
For the treatment of erectile dysfunction (ED)
Warnings
For adult men only.
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
• 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.
When Using This Product You May Experience:
headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances
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.
Contraindications
Not for use in pregnant or breastfeeding women
Not for use in children under 18 years
Inactive Ingredients
Film-forming polymers, stabilizers, sweeteners, flavoring agents.
* Please review the disclaimer below.
