FDA label f74c67ec-3181-4466-ac3f-4c6c973fa89f

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
0e55f510-8c43-4b3a-a6d3-c44d8169cb37
SPL ID
f74c67ec-3181-4466-ac3f-4c6c973fa89f
Version
6
Effective date
2017-05-30
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:04

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 Do not use if you cannot swallow without chewing Ask a doctor before use if -you have a sudden change in bowel habits that lasts over 2 weeks -stomach pain, nausea or vomiting When using this product -do not use within 1 hour after taking an antacid or milk -do not chew or crush tablet -you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if -you have rectal bleeding or fail to have a bowel movement after use. These may be signs of a serious condition. -you need to use a laxative for more than 1 week Pregnancy/Breastfeeding If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children This package is intended for institutional use only., Keep out of reach of children. In case of accidental 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.