FDA.reportPublic FDA data

FDA label 0b50b7ba-44ec-624f-e063-6294a90a02fd

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
37a1eb24-8439-4ea4-a0f6-29f8c242f292
SPL ID
0b50b7ba-44ec-624f-e063-6294a90a02fd
Version
3
Effective date
2023-11-29
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:15

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For rectal use only. Ask a doctor before use in case of bleeding. When using this product , do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask doctor if symptoms persist for more than 7 days or worsen. This could be a sign of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children If swallowed , get medical help or contact a Poison Control Center right away

warnings

If swallowed , get medical help or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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