FDA label 1f485026-cf10-464c-b4e4-0d7f51f07537

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
80110b85-6709-44b9-95c0-ba82f0e82871
SPL ID
1f485026-cf10-464c-b4e4-0d7f51f07537
Version
2
Effective date
2018-08-06
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 02:20:59

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 hours 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 of age • 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 • a dehydration condition 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 early symptoms of dehydration including • feeling thirsty • 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.

Reported adverse events (FAERS/openFDA)#

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