FDA label 388b5efd-9bb1-40d2-89b0-7ad1ff5b923e

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: 03342549-66a9-4002-8b9c-fefef01a326a
SPL ID: 388b5efd-9bb1-40d2-89b0-7ad1ff5b923e
Version: 3
Effective date: 2021-01-22
Source export date: 2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:22

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		388b5efd-9bb1-40d2-89b0-7ad1ff5b923e	id
spl set id		03342549-66a9-4002-8b9c-fefef01a326a	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

WARNINGS: Stop use if conditions persist or worsen. If pregnant or breast feeding ask a healthcare professional before use. Keep out of reach of children. Contains Alcohol. In case of overdose, get medical help or contact a Poison Control Center right away. OTHER INFORMATION: Do not use if tamper evident seal is broken or missing. Store in a cool dry place.

Reported adverse events (FAERS/openFDA)#

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