FDA.reportPublic FDA data

FDA label 813ebf22-8bb6-66fc-e053-2a91aa0a7d7a

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
989d71bc-7e40-46d8-9491-eeaef2d09a40
SPL ID
813ebf22-8bb6-66fc-e053-2a91aa0a7d7a
Version
8
Effective date
2019-02-06
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:28

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: Warnings Do not use laxative products for longer that one week unless directed to do so by a doctor and if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have: Abdominal pain, nausea, vomiting, noticed 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 or if you fail to have a bowel movement after use. These could be signs of a serious condition. If pregnant or breast-feeding , ask a doctor before use.

Reported adverse events (FAERS/openFDA)#

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