FDA label f291e7ed-a8b2-3b29-e053-2995a90ad428

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
a7180a08-4a21-4c8b-af2e-ef6862b41fde
SPL ID
f291e7ed-a8b2-3b29-e053-2995a90ad428
Version
7
Effective date
2023-01-18
Source export date
2026-11-06
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:54:40

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 • If condition worsens or does not improve within 7 days, consult a doctor. • Do not exceed the recommended daily dosage unless directed by a doctor. • In case of bleeding, consult a doctor promptly. • Do not put this product into the rectum by using fingers or any mechanical device or applicator. • Certain persons can develop allergic reactions to ingredients in this product. • If the symptom, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.