FDA label ef0ac0d3-b319-4ff8-94d3-825ebdf99a8c

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
ced9d373-d26b-4e55-84eb-8e59418d72e0
SPL ID
ef0ac0d3-b319-4ff8-94d3-825ebdf99a8c
Version
1
Effective date
2014-08-21
Source export date
2026-11-06
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:42:23

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

Cautions and Warnings: ​Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Précaution(s) et mise(s) en garde: Consulter un praticien de soins de santé si les symptômes persistent ou s'aggravent. Consulter un praticien de soins de santé avant d'en faire l'usage si vous êtes enceinte ou allaitante.

Reported adverse events (FAERS/openFDA)#

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