FDA label e12c16df-924d-4cca-9370-88a02c2379dd

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
777e48d8-95d7-414b-97cb-ddd0c2b3e313
SPL ID
e12c16df-924d-4cca-9370-88a02c2379dd
Version
3
Effective date
2018-06-15
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:55:59

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 dosage 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, or uncorrected electrolyte abnormalities in children under 6 years old for bowel cleansing Ask a doctor before use if you have abdominal pain, nausea, or vomiting have kidney disease have heart problems have a sudden change in bowel habits lasting more than 2 weeks have already used a laxative for more than 3 days are dehydrated are 55 years of age or older are on a sodium-restricted diet under a doctor's care for any medical condition are taking any other prescription or non-prescription medications 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 use more than directed. Serious side effects may occur from excess dosage. do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you do not have a bowel movement within 6 hours you have any symptoms that your body is losing more fluid than you are drinking you have early 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 right away: 800-222-1222.

Reported adverse events (FAERS/openFDA)#

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