FDA label f3be8854-359f-49fd-b85c-e52fa44b28ab

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
f3150f5a-02dc-40dc-b077-136ecb0c4cd1
SPL ID
f3be8854-359f-49fd-b85c-e52fa44b28ab
Version
4
Effective date
2021-03-24
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:04

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. Hold close to mouth and spray 3 times directly under the tongue every 15 minutes, extend interval as symptoms improve or as directed by a health care professional. Manufactured according to HPUS standards. CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenar a no mas de 30C. INACTIVE INGREDIENT: USP Ethanol Alcohol 20% Mfg. By: OHM PHARMA INC. Mineral Wells, TX 76067 R.S. INVIMA: MH2012-0001886 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.