FDA.reportPublic FDA data

FDA label 03727d50-c6a9-4773-910f-a09f16c33b85

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
44e17773-d5e6-4962-8fa0-fa3bdda04c5d
SPL ID
03727d50-c6a9-4773-910f-a09f16c33b85
Version
2
Effective date
2015-03-09
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:42

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 Do not use ■ for longer than one week ■ when abdominal pain, nausea or vomiting are present Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks Stop use and ask a doctor if ■ you have rectal bleeding ■ you fail to have a bowel movement after use of this product, this may indicate a serious condition 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.