FDA label 58865b21-59a8-4957-bfa1-e384a4328c96

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
82014bd3-5713-49fa-9169-ec1449455650
SPL ID
58865b21-59a8-4957-bfa1-e384a4328c96
Version
6
Effective date
2016-01-15
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:31:05

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 right away.

Reported adverse events (FAERS/openFDA)#

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