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: 2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:23:16

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		ef0ac0d3-b319-4ff8-94d3-825ebdf99a8c	id
spl set id		ced9d373-d26b-4e55-84eb-8e59418d72e0	set_id

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.