FDA label 6b770ed5-fd3f-4797-a693-6724b73c7758

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
4d022ef5-fa76-4e50-b56b-759bc35754ab
SPL ID
6b770ed5-fd3f-4797-a693-6724b73c7758
Version
1
Effective date
2017-09-28
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 01:35:29

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 Do not use when abdominal pain, nausea, or vomiting are present for more than one week unless directed by a doctor Ask a doctor before use if you are taking mineral oil have noticed a sudden change in bowel habits that lasts more than 2 weeks Stop use and ask a doctor if you have no bowel movement within 3 days you have rectal bleeding these could be signs of a serious condition a skin rash occurs you experience throat irritation

Reported adverse events (FAERS/openFDA)#

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