FDA.reportPublic FDA data

FDA label b4df1ecc-7ebe-050b-e053-2a95a90abfc9

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
221d73c1-8970-4468-8924-f6d450ab78b4
SPL ID
b4df1ecc-7ebe-050b-e053-2a95a90abfc9
Version
3
Effective date
2020-11-24
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:26:01

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 an allergy or hypersensitivity to components of the formula in children under 12 years of age as a substitute for sleep Ask a doctor before use if you are under a doctor's care for any serious condition taking any other drug Stop use and ask a doctor if condition worsens symptoms persist for more than 15 days or clear up and occur again within a few days If pregnant or breast feeding , ask a health care professional before use.