FDA label 091d5a34-dbbb-455e-9825-9b807711eca8

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
894e79d9-beed-4dcc-8f07-7745e798daef
SPL ID
091d5a34-dbbb-455e-9825-9b807711eca8
Version
4
Effective date
2021-05-06
Source export date
2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:30:46

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 give to children under 12 years of age. If pregnant or breast-feeding , ask a health professional before use. If sleeplessness or nervous tension persists continuously for more than two weeks, a health professional should be consulted. Insomnia may be a symptom of serious underlying medical illness. Due to the homeopathic nature of WellMind Calming, a temporary worsening in symptoms (initial aggravation) may occur, but often resolves quickly. Allergic (hypersensitivity) skin reactions may occur in very rare casses. Do not use if known sensitivity to Wellmind Calming or any of its ingredients exists.

Reported adverse events (FAERS/openFDA)#

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