FDA label 433afbe0-f399-4a7e-9f0c-36412ddc91b6

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: f7323a2b-1777-4d8f-a2ca-328bf2018d97
SPL ID: 433afbe0-f399-4a7e-9f0c-36412ddc91b6
Version: 5
Effective date: 2024-12-29
Source export date: 2026-10-22
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/caf5811f980ee3e51e5ea59ba12f125bb3738ddeec8265aac8812df797bc62f1/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 00:26:19

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		433afbe0-f399-4a7e-9f0c-36412ddc91b6	id
spl set id		f7323a2b-1777-4d8f-a2ca-328bf2018d97	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 Do not use • if you are now taking aprescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy

Reported adverse events (FAERS/openFDA)#

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