FDA label 83ecf12d-3f16-1124-e053-2991aa0a0764

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
04d87f9e-cafc-4b40-9d9e-d13740335c15
SPL ID
83ecf12d-3f16-1124-e053-2991aa0a0764
Version
2
Effective date
2019-03-12
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:15

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 Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. 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.

Reported adverse events (FAERS/openFDA)#

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