FDA.reportPublic FDA data

FDA label 77e4a56d-471d-49d8-e053-2991aa0a06ec

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
32307aff-40d3-686c-e054-00144ff8d46c
SPL ID
77e4a56d-471d-49d8-e053-2991aa0a06ec
Version
3
Effective date
2018-10-10
Source export date
2026-08-01
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/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:37:04

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 last over 2 weeks Stop use and ask a doctor if you have no bowel movement after 3 days you have rectal bleeding These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.