FDA label 8aa9edc5-30d9-4be7-b7f3-fe98f0a470af

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
df5055cf-5cdc-4928-8287-f1ba37b6f8a0
SPL ID
8aa9edc5-30d9-4be7-b7f3-fe98f0a470af
Version
2
Effective date
2017-11-18
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:19

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 Ask a doctor before use if you have • abdominal pain, nausea or vomiting • noticed a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product • do not chew or crush tablets • do not give to children under 6 years of age or to persons who cannot swallow without chewing, unless directed by a doctor • do not use within 1 hour after taking an antacid or milk • abdominal discomfort, faintness, and cramps may occur Stop use and ask a doctor if • you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition. • you need to use a laxative for more than one week 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.