DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Tadalafil (20 mg) Vardenafil

Inactive Ingredients

Hypromelloses Sucralose Sucrose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-24

Medication Information

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Dosage and Administration

For external use only.

Contraindications

Pregnant or breastfeeding women

Children under 18 years

Description

Tadalafil 20 mg – Erectile dysfunction treatment Vardenafil 20 mg – Erectile dysfunction treatment

Uses

For the treatment of erectile dysfunction (ED)

Warnings

For prescription use only (Rx only).

Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension.

Do not use if allergic to tadalafil, vardenafil, or any component of this product.

Do Not Use

heart problems, history of heart attack, irregular heartbeat, or chest pain

high or low blood pressure

liver or kidney disease

vision or hearing problems

history of priapism (painful or prolonged erection lasting >4 hours)

Inactive Ingredients

Film-forming polymers, stabilizers, sweeteners, flavoring agents.

Principal Display Panel

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.

Active Ingredients (in Each Film)

Tadalafil 20 mg – Erectile dysfunction treatment

Vardenafil 20 mg – Erectile dysfunction treatment

When Using This Product You May Experience:

headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances

Structured Label Content

Uses

For the treatment of erectile dysfunction (ED)

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Warnings

For prescription use only (Rx only).

Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension.

Do not use if allergic to tadalafil, vardenafil, or any component of this product.

Do Not Use (Do not use)

heart problems, history of heart attack, irregular heartbeat, or chest pain

high or low blood pressure

liver or kidney disease

vision or hearing problems

history of priapism (painful or prolonged erection lasting >4 hours)

Contraindications

Pregnant or breastfeeding women

Children under 18 years

Inactive Ingredients (Inactive ingredients)

Film-forming polymers, stabilizers, sweeteners, flavoring agents.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

For external use only.

Stop Use and Ask A Doctor If: (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.

Active Ingredients (in Each Film) (Active ingredients (in each film))

Tadalafil 20 mg – Erectile dysfunction treatment

Vardenafil 20 mg – Erectile dysfunction treatment

When Using This Product You May Experience: (When using this product you may experience:)

headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances

Advanced Ingredient Data

[{"name": "TADALAFIL", "unii": "742SXX0ICT", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "VARDENAFIL", "unii": "UCE6F4125H", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the treatment of erectile dysfunction (ED)", "Purpose": "Phosphodiesterase type 5 (PDE5) inhibitors", "Warnings": "For prescription use only (Rx only). Do not use if you are taking any form of nitrate medications (such as nitroglycerin) due to the risk of severe hypotension. Do not use if allergic to tadalafil, vardenafil, or any component of this product.", "Do not use": "heart problems, history of heart attack, irregular heartbeat, or chest pain high or low blood pressure liver or kidney disease vision or hearing problems history of priapism (painful or prolonged erection lasting >4 hours)", "Contraindications": "Pregnant or breastfeeding women Children under 18 years", "Inactive ingredients": "Film-forming polymers, stabilizers, sweeteners, flavoring agents.", "Dosage and administration": "For external use only.", "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.", "Active ingredients (in each film)": "Tadalafil 20 mg – Erectile dysfunction treatment Vardenafil 20 mg – Erectile dysfunction treatment", "When using this product you may experience:": "headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances"}