Indications and uses
For the treatment of erectile dysfunction (ED)
For the treatment of erectile dysfunction (ED)
Take one film by mouth, placed on the tongue to dissolve. Use 0.5 to 4 hours before sexual activity. Do not take more than once per day.
Tadalafil 30 mg
Vardenafil 10 mg
Phosphodiesterase type 5 (PDE5) inhibitors
For the treatment of erectile dysfunction (ED)
For adult men only.
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
heart conditions, 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)
are over 65 years of age (higher risk of side effects, medical supervision advised)
Take one film by mouth, placed on the tongue to dissolve.
Use 0.5 to 4 hours before sexual activity.
Do not take more than once per day.
headache, flushing, indigestion, nasal congestion, dizziness, muscle pain, back pain, nausea, rash, or visual disturbances
you experience chest pain, fainting, sudden vision or hearing loss
an erection lasts longer than 4 hours (priapism). This is a medical emergency.
Avoid use with: Nitrates, α-adrenergic blockers (e.g., tamsulosin), strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, which may increase vardenafil plasma concentration).
Use with caution with: Antihypertensive drugs, alcohol (may enhance hypotensive effects).
Keep out of reach of children
Not for use in pregnant or breastfeeding women
Not for use in children under 18 years
Film-forming polymers, stabilizers, sweeteners, flavoring agents.
| Class | Version | Type | Effective |
|---|---|---|---|
| TADALAFIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| VARDENAFIL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b90b74cb-f6c8-3798-d11c-73b8768b278a | Product name | 8 | 20250317 |
| 0fe0157c-95a7-4870-ae64-de9f3fa874ae | Product name | 1 | 20250227 |
| 20ae0006-d78c-4dba-9e3e-6ae424841903 | Product name | 1 | 20250127 |
| b86a08b7-54cc-440b-ad4a-3e530ccd8324 | Product name | 6 | 20230421 |
| 7a02e74a-2844-42af-84a8-96bae57351cf | Product name | 1 | 20230313 |
| 928d249c-35c3-4d88-a9ef-cf2f2e31b96f | Product name | 1 | 20220706 |
| f2f15561-f1f1-39f4-fff4-873c88c535cd | Product name | 4 | 20210224 |
| 9c8b57d3-6030-411c-8a17-97b4b8f0ea17 | Product name | 3 | 20200708 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87436-021-01 | CHBO | 1 in 1 POUCH | FILM, SOLUBLE | 1 | 1 | |
| 87436-021-01 | CHBO | 4 in 1 BOX | FILM, SOLUBLE | 4 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 87436-021 | 87436-021-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| VARDENAFIL | UCE6F4125H | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| TADALAFIL | 742SXX0ICT | ACTIB |
| SUCROSE | C151H8M554 | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4ad86186-4acd-6204-e063-6394a90ac62e | 4ad86186-4acc-6204-e063-6394a90ac62e | 2026-02-15 | Warnings | 4ad86186-4acd-6204-e063-6394a90ac62e 4ad86186-4acc-6204-e063-6394a90ac62e |
Adverse event summaries are temporarily unavailable. Other product information remains available.