FDA label dfb4674b-a2a9-450f-b017-05018a142a64

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
6bb7cbe4-5960-4340-9b1f-cffbaf461d95
SPL ID
dfb4674b-a2a9-450f-b017-05018a142a64
Version
4
Effective date
2021-03-24
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:23

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 niños. DIRECTIONS: Shake 10 times before use. Spray 3 times under the tongue 2-3 times a day or as directed by 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 30C. INACTIVE INGREDIENT: USP Ethanol Alcohol 20% Mfg. By: OHM PHARMA INC. Mineral Wells, TX 76067 R.S. INVIMA: MH2010-0001591 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.