FDA label 349e470d-0eda-4b9e-a6f6-075dc6e5c4a3

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: 41d78fb9-7da7-433d-8d35-30280c5627a0
SPL ID: 349e470d-0eda-4b9e-a6f6-075dc6e5c4a3
Version: 4
Effective date: 2021-12-16
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:04:24

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		349e470d-0eda-4b9e-a6f6-075dc6e5c4a3	id
spl set id		41d78fb9-7da7-433d-8d35-30280c5627a0	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 have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have consistent sleeplessness that persists for more than two weeks. Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Store at room temperature.

Reported adverse events (FAERS/openFDA)#

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