FDA label 5544b099-31c6-4bae-87a6-fe4c81e1e427

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
9fc4b1cf-8f29-45e5-9b36-6e097dce18cc
SPL ID
5544b099-31c6-4bae-87a6-fe4c81e1e427
Version
4
Effective date
2018-09-14
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:50:18

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 For oral use only. Gallstones, occlusion of the bile ducts, jaundice and any other unclear or persistent discomfort in the upper abdomen may be serious. Consult a doctor promptly if any of these symptoms occur. Do not use if you are allergic to Taraxacum, Carduus marianus or other plants from the daisy family (Compositae) if you suffer from liver diseases Stop use and ask a doctor if symptoms persist for more than 7 days, worsen or new symptoms occur. If pregnant or breast-feeding, ask a health professional before use. Keep this and all medicines out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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