FDA label c1ed5356-714f-418f-89f9-36bb4093f8df

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: cd0fc3f6-395c-4790-abb7-a5bd30a400c1
SPL ID: c1ed5356-714f-418f-89f9-36bb4093f8df
Version: 1
Effective date: 2013-05-24
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:31

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		c1ed5356-714f-418f-89f9-36bb4093f8df	id
spl set id		cd0fc3f6-395c-4790-abb7-a5bd30a400c1	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 Ask a doctor before use in children younger than 16 years. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Sleeplessness may be a symptom of serious underlying medical illness. If pregnant or breastfeeding , ask a health care professional before use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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