FDA label 9aa3419d-25d8-3a97-e053-2a95a90abbe9

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: 3b46626f-9bd0-4c6a-9e7f-2c34b9001e66
SPL ID: 9aa3419d-25d8-3a97-e053-2a95a90abbe9
Version: 7
Effective date: 2019-12-26
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:29:12

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		9aa3419d-25d8-3a97-e053-2a95a90abbe9	id
spl set id		3b46626f-9bd0-4c6a-9e7f-2c34b9001e66	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

Stop use and ask a doctor if discomfort persists for more than 8 hours. Do not use if you have allergy or hypersensitivity to components of the formula. Do not give to children under 12 years of age. For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur consult a doctor. Keep out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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