FDA label 6652723f-d9ef-47c2-bdfe-acf4f6d32fb3

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: fafef302-c7f3-4bcb-b876-c6e196b5425b
SPL ID: 6652723f-d9ef-47c2-bdfe-acf4f6d32fb3
Version: 2
Effective date: 2021-10-25
Source export date: 2026-11-06
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:53:02

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		6652723f-d9ef-47c2-bdfe-acf4f6d32fb3	id
spl set id		fafef302-c7f3-4bcb-b876-c6e196b5425b	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: Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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