FDA label 44599d58-4efa-2fc3-e063-6394a90a7bd0

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
0eb3a81d-d178-cc52-e063-6394a90a9697
SPL ID
44599d58-4efa-2fc3-e063-6394a90a7bd0
Version
2
Effective date
2025-11-24
Source export date
2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:20:28

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 When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put htis product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return within a few days Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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