FDA label ebab0f1d-8e32-4937-af63-c025dafdffe1

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
d2960e35-1b45-4d58-b63b-741795bf9f0a
SPL ID
ebab0f1d-8e32-4937-af63-c025dafdffe1
Version
1
Effective date
2009-12-23
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 02:21:26

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. Do not use more than one per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor if seal under product lid is damaged, missing or broken. Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks if you are pregnant or nursing a baby Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using a laxative. This 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.