3f80b8cc-5140-a70e-e063-6394a90ac265

SPL v2

SPL

SPL Set ID 3f80b8cc-5140-a70e-e063-6394a90ac265

Route

topical

Published

Effective Date 2025-08-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

vardenafil (10 mg) tadalafil (30 mg)

Inactive Ingredients

hypromelloses sucralose sucrose

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-08-24

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.

Contraindications

Not for use in pregnant or breastfeeding women Not for use in children under 18 years

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

Description

Tadalafil 30 mg – Erectile dysfunction treatment Vardenafil 10 mg – Erectile dysfunction treatment

Medication Information

Warnings

For adult men only.

Uses

For the treatment of erectile dysfunction (ED)

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

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.

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.

Description

Tadalafil 30 mg – Erectile dysfunction treatment Vardenafil 10 mg – Erectile dysfunction treatment

Principal Display Panel

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

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 30 mg – Erectile dysfunction treatment

Vardenafil 10 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

Warnings

For adult men only.

Uses

For the treatment of erectile dysfunction (ED)

Purpose

Phosphodiesterase type 5 (PDE5) inhibitors

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.

Contraindications

Not for use in pregnant or breastfeeding women

Not for use in children under 18 years

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Do Not Use If You: (Do not use if you:)

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 30 mg – Erectile dysfunction treatment

Vardenafil 10 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": "VARDENAFIL", "unii": "UCE6F4125H", "classCode": "ACTIB", "strengthNumerator": "10", "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": ""}, {"name": "TADALAFIL", "unii": "742SXX0ICT", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the treatment of erectile dysfunction (ED)", "Purpose": "Phosphodiesterase type 5 (PDE5) inhibitors", "Warnings": "For adult men only.", "Contraindications": "Not for use in pregnant or breastfeeding women Not for use in children under 18 years", "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", "Inactive ingredients": "Film-forming polymers, stabilizers, sweeteners, flavoring agents.", "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.", "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 30 mg – Erectile dysfunction treatment Vardenafil 10 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:47.667807 · Updated: 2026-03-14T23:11:35.907821