FDA.reportPublic FDA data

FDA label 41ec3108-802d-0138-e063-6394a90a7efe

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
5d8e5726-5401-898c-e053-2991aa0aca76
SPL ID
41ec3108-802d-0138-e063-6394a90a7efe
Version
10
Effective date
2025-10-24
Source export date
2026-11-06
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:15:10

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 May cause rectal discomfort or a burning sensation. Ask a doctor before using any laxative if you have abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative formore than 1 week Stop use and consult a doctor if you have rectal bleeding no bowel movement after using this product These symptoms may indicate a serious condition. Keep out of reach of children 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.