FDA label a495bf41-709c-cba8-e053-2995a90a291f

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
51bbe2e8-fd0a-468c-8ef0-28f6df270b63
SPL ID
a495bf41-709c-cba8-e053-2995a90a291f
Version
4
Effective date
2020-05-01
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:20:47

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 Pregnancy/Breastfeeding ask a health professions before use. Keep out of reach of children 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.