FDA.reportPublic FDA data

FDA label 4c396dba-4f4d-4abe-b006-b2bbf09689ac

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
0382bb0d-38bb-4b6b-b804-d0e4482081a8
SPL ID
4c396dba-4f4d-4abe-b006-b2bbf09689ac
Version
4
Effective date
2021-10-19
Source export date
2026-08-17
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/02a497ed455224db2b03c6e57c80c30915819e1b465153908a5d9e68e3a47b21/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 08:05:58

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 vomiting a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are presently taking mineral oil. Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using a laxative. These could be sign of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away