FDA label d7429859-b55f-431a-9d32-0fcf32980f61

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
6f68624b-0c3a-4962-b629-a54f175ed8dd
SPL ID
d7429859-b55f-431a-9d32-0fcf32980f61
Version
3
Effective date
2021-03-24
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:45

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

Medicamento Homeopatico. Mantengase fuera del alcance de los ninos. DIRECTIONS: Shake 10 times before use. Spray 3 times directly under the tongue 2-3 times a day or as directed by a health care professional. Children under 12: use half the adult dose. Manufactured according to HPUS standards. CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenat a no mas de 30°C. INACTIVE INGREDIENTS: USP Ethanol Alcohol 20% Mfg. By: OHM PHARMA INC. Mineral Wells, TX 76067 R.S. INVIMA: MH2011-0001769 Importado y Distribuido para Colombia por: OHM PHARMA COLOMBIA Ltda. DG. 39 NO 34 C SUR 30 Envigado, Antioquia Tel: (57) 4-379 5995

Reported adverse events (FAERS/openFDA)#

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