FDA Label for Esokalli Testosterone Booster Oral Dissolving Film
View Indications, Usage & Precautions
Esokalli Testosterone Booster Oral Dissolving Film Product Label
The following document was submitted to the FDA by the labeler of this product Guangzhou Yixin Cross-border E-commerce Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Film)
Tadalafil 30 mg – Erectile dysfunction treatment
Vardenafil 10 mg – Erectile dysfunction treatment
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.
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