FDA label 719782b0-83b5-44f2-ae68-5073cb5b5307

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
6d2f1549-a692-4a37-b13f-64f858232967
SPL ID
719782b0-83b5-44f2-ae68-5073cb5b5307
Version
9
Effective date
2022-10-31
Source export date
2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:31:55

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 more than 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(s) -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 of a laxative. These could be signs of a serious condition. -you need to use a laxative for more than 1 week If pregnant or breastfeeding 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.