FDA label 8496eff2-4176-47e3-a48b-bfe15bc8665c

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: 1f9790cc-f2b1-4564-bd50-3dc429a4d9fb
SPL ID: 8496eff2-4176-47e3-a48b-bfe15bc8665c
Version: 2
Effective date: 2014-08-19
Source export date: 2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:48:52

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		8496eff2-4176-47e3-a48b-bfe15bc8665c	id
spl set id		1f9790cc-f2b1-4564-bd50-3dc429a4d9fb	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 Warnings: Do not give to children under 12 years of age. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children . If sleeplessness or nervous tension persist continuously for more than two weeks, a healthcare provider should be consulted. Insomnia may be a symptom of serious underlying medical illness. Do not use if known sensitivity to Calming or any of its ingredients exists.

Reported adverse events (FAERS/openFDA)#

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