FDA label 6d3549e6-00fd-4095-b44c-99eb0937df61

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
800fb383-3bb3-424a-a729-d9cd57a37a1e
SPL ID
6d3549e6-00fd-4095-b44c-99eb0937df61
Version
4
Effective date
2024-12-12
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:53:02

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 one 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 two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. If you are pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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