FDA label 197c2c20-da7d-488e-96e1-1ab91a2a9e28

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
6b321ab8-a5ce-46e5-8c54-900b39d4cfff
SPL ID
197c2c20-da7d-488e-96e1-1ab91a2a9e28
Version
4
Effective date
2017-12-27
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 03:02:49

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 Dosage warning Taking more than the recommended dose in 24 hour can be harmful. Do not use if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities in children under 5 years old for bowel cleansing Ask a doctor before use if you have abdominal pain, nausea, or vomiting kidney disease heart problems a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than a week dehydration Ask a doctor or pharmacist before use if you are on a sodium restricted diet under a doctor's care for any medical condition taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have any rectal bleeding do not have a bowel movement within 6 hours have any symptoms that your body is losing more fluid than you are drinking have symptoms of dehydration including thirstiness dizziness urinating less often than normal vomiting These symptoms may indicate a serious condition. 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 immediately: 800-222-1222.

Reported adverse events (FAERS/openFDA)#

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