FDA label e6fcb794-dcf0-4b1f-8d2e-81867647b365

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
c7486d55-7f51-415b-8ebb-d1120df709fb
SPL ID
e6fcb794-dcf0-4b1f-8d2e-81867647b365
Version
6
Effective date
2016-01-15
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:23

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 in children under 6 years of age in persons who cannot swallow without chewing Ask a doctor before use if you have abdominal pain nausea vomiting sudden change in bowel movements that persists over a period of 2 weeks When using this product do not use for a period longer than 1 week unless directed by a doctor you may experience abdominal discomfort, faintness and cramps Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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