FDA label 394a4cf5-15a8-458b-a3df-5639ef581825

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
a8b9babd-bcd7-4d1e-a61b-0702f6696b79
SPL ID
394a4cf5-15a8-458b-a3df-5639ef581825
Version
4
Effective date
2024-05-22
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:43

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 if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea, or vomiting are present for longer than 1 week, unless directed by a doctor. Prolonged or continued use of this product can lead to laxative dependency and loss of normal bowel function. Serious side effects from prolonged use or overdose can occur Caution do not chew or crush do not give to children under 6 years of age or to persons who cannot swallow without chewing do not take this product within 1 hour after taking an antacid and/or milk this product may cause abdominal discomfort, faintness, rectal burning, and mild cramps Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks. Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use of a laxative 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.