FDA label 57fdf42d-b111-49c8-be2a-402b8e7d6a71

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: c01d363e-2ece-43dd-86b6-27e6519f37e5
SPL ID: 57fdf42d-b111-49c8-be2a-402b8e7d6a71
Version: 2
Effective date: 2015-05-12
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 05:29:55

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		57fdf42d-b111-49c8-be2a-402b8e7d6a71	id
spl set id		c01d363e-2ece-43dd-86b6-27e6519f37e5	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

Warning: Use only as directed. * 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. * Tamper Sealed: Sealed for your protection. Do not use if seal around neck is broken or missing.

Reported adverse events (FAERS/openFDA)#

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