FDA.reportPublic FDA data

FDA label a1c3daa5-cf02-4ab6-9ed2-f98391974d9f

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
923f8ca3-7488-eb2d-d745-1e5dd79a7bc6
SPL ID
a1c3daa5-cf02-4ab6-9ed2-f98391974d9f
Version
4
Effective date
2025-04-18
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:26:34

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 For rectal use only Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to an enlarged prostate Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression When using this product • do not use more than directed Stop use and ask a doctor if • symptoms get worse or do not get better in 7 days • bleeding occurs

Reported adverse events (FAERS/openFDA)#

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