FDA.reportPublic FDA data

FDA label bcf5bc3f-60c9-bfd7-e053-2a95a90a97a7

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
bcf5bc3f-60c8-bfd7-e053-2a95a90a97a7
SPL ID
bcf5bc3f-60c9-bfd7-e053-2a95a90a97a7
Version
1
Effective date
2021-03-07
Source export date
2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:55:48

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 for more than one week unless directed by a doctor Ask a doctor before use if you have abdominal pain, nausea, or vomiting are taking mineral oil noticed a sudden change in bowel habits that last over 2 weeks Stop use and ask a doctor if you have no bowel movement within 12 hours you have rectal bleeding 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.