FDA.reportPublic FDA data

FDA label e7966e97-7072-42cd-b9ed-491f9e3a5163

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
dac7bc58-649e-493b-92e0-b164ca43b3dd
SPL ID
e7966e97-7072-42cd-b9ed-491f9e3a5163
Version
1
Effective date
2013-04-03
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 03:04:26

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 Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks. Ask a doctor before use in children younger than 12 years. Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement after use of a laxative occurs because this may indicate a serious condition symptoms persist over a period of more than 1 week. If pregnant or breastfeeding , ask a health care professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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