FDA.reportPublic FDA data

FDA label bdf08eb0-ed3d-4ce9-81fc-4e9ec5680603

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
f447101a-e89e-4df8-9cf5-ceaa71de28fb
SPL ID
bdf08eb0-ed3d-4ce9-81fc-4e9ec5680603
Version
1
Effective date
2011-05-20
Source export date
2026-08-17
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/f2a007a22a89560a66943d28521709913d039c2d0cd7e278faf1082cd194c72c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:14:05

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a physician. Avoid contact with the eye. If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a physician.