FDA.reportPublic FDA data

FDA label 3862274d-b4a1-49f2-a3e0-9a6c26e8271c

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
0702f396-acd3-4b28-8a27-cc7c740f9c56
SPL ID
3862274d-b4a1-49f2-a3e0-9a6c26e8271c
Version
2
Effective date
2012-01-09
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:33

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 of 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 two weeks already used a laxative for more 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.