FDA label ca8b2a21-5b90-4f32-a05c-c608101d9cb1

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
91bb0407-9c41-4263-bf74-5ce86e494b7a
SPL ID
ca8b2a21-5b90-4f32-a05c-c608101d9cb1
Version
3
Effective date
2014-08-20
Source export date
2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:05

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 breastfeeding, ask a healthcare provider before use. Keep out of reach of children. If sleeplessness or nervous tension persists continuously for more than two weeks, a healthcare provider should be consulted. Insomnia may be a symptom of serious underlying medical illness. Due to the homeopathic nature of Neurexan® tablets a temporary worsening in symptoms (initial aggravation) may occur, but often resolves quickly. Allergic (hypersensitivity) skin reactions may occur in very rare cases. Do not use if known sensitivity to Neurexan® or any of its ingredients exists.

Reported adverse events (FAERS/openFDA)#

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