FDA label 8b923afe-00c3-4f52-bb76-beec91726d93

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
5feebf0e-96d1-4c81-9383-da31e274a8dd
SPL ID
8b923afe-00c3-4f52-bb76-beec91726d93
Version
5
Effective date
2025-05-30
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:58:18

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 seal is broken or missing. As with any drug, ask a doctor before use if pregnant or breastfeeding. This formula is highly diluted homeopathic and is generally safe for all ages. Call your provider if symptoms worsen after 7 days. Homeopathic Remedies have no known drug interactions. Keep this and all medication out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately. The active homeopathic ingredients are diluted beyond 1 part per million.

Reported adverse events (FAERS/openFDA)#

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