FDA label 5b17afd8-de62-4684-b556-d2846eb214b8

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
5b17afd8-de62-4684-b556-d2846eb214b8
SPL ID
5b17afd8-de62-4684-b556-d2846eb214b8
Version
1
Effective date
2011-09-07
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:05:24

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 ° for longer than one week ° when abdominal pain, nausea or vomiting are present. Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks. Stop use and ask a doctor if ° you have rectal bleeding ° you fail to have a bowel movement after use of this product, this may indicate a serious condition. 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.

Reported adverse events (FAERS/openFDA)#

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