FDA label ad47a413-007e-49a8-82f1-9f1af72aa9db

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
72181ad2-160f-4018-a5d6-c07923d139ac
SPL ID
ad47a413-007e-49a8-82f1-9f1af72aa9db
Version
4
Effective date
2021-03-24
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:02

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 nios. DIRECTIONS: Shake 10 times before use. Spray 3 times directly under the tongue 2-3 times during the night or as directed by a health professional. Children under 12 years use half adult dose. Manufactured according to HPUS standards. CONDICIONES DE ALMACENAMIENTO: Conservar el producto protegido del calor, luz y humedad. Alcamacenat a no mas de 30C. INACTIVE INGREDIENT: USP Ethanol Alcohol 20% Mfg. By: OHM PHARMA INC. Mineral Wells, TX 76067 R.S. INVIMA: MH2011-0001779 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.