FDA.reportPublic FDA data

FDA label 3363ba44-965f-4e58-e063-6394a90a034e

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
48555cc1-a711-411f-a384-550116da1d3c
SPL ID
3363ba44-965f-4e58-e063-6394a90a034e
Version
12
Effective date
2025-04-22
Source export date
2026-08-01
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/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:23:14

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 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 professional before use.