FDA.reportPublic FDA data

FDA label e7e0e9bc-0f81-45f4-8758-ca700983c9b6

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
c3328938-35af-48e9-abe9-0a5f767f2d9e
SPL ID
e7e0e9bc-0f81-45f4-8758-ca700983c9b6
Version
2
Effective date
2014-06-02
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 02:23:29

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 Warnings Do not use ■ if you are currently taking mineral oil, unless directed by a doctor ■ when abdominal pain, nausea, or vomiting are present ■ for longer than 1 week, unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks. Stop use and ask a doctor if ■ you have rectal bleeding ■ you fail to have a bowel movement after use If pregnant or breast-feeding, ask a health care professional before use.

Reported adverse events (FAERS/openFDA)#

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