FDA label 0bf446ec-917d-4690-a698-1c7240c3ce7f

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
066b9348-5585-4d43-aef7-f440d0492fd8
SPL ID
0bf446ec-917d-4690-a698-1c7240c3ce7f
Version
2
Effective date
2017-08-08
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:14

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 This package is intended for institutional use only. Do not use the product if abdominal pain, nausea or vomiting are present. Consult a physician before the use of this product. Ask a doctor before use if: You have noticed a sudden change in bowel habits that persist over a period of 2 weeks. You are presently taking mineral oil. Stop use and ask a doctor if: Rectal bleeding or failure to have a bowel movement occur after use, which may indicate a serious condition. You need to use a laxative for more than 1 week. If you are pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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