FDA label 80f1c25e-d550-4979-bf74-9d117085595e

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
24fb13b6-abf9-4006-a8da-56200464dac6
SPL ID
80f1c25e-d550-4979-bf74-9d117085595e
Version
2
Effective date
2011-12-06
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 02:48:24

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 presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks. Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition you need to use a stool softener for more than 1 week. If pregnant or breastfeeding 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 immediately.

Reported adverse events (FAERS/openFDA)#

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