FDA label 8de464cc-5bf0-444b-833d-702f3dec5a85

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
ec9a6121-922e-40f7-a2a4-b2261298753e
SPL ID
8de464cc-5bf0-444b-833d-702f3dec5a85
Version
1
Effective date
2019-02-14
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:24

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 in the eyes. • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms) If pregnant, trying to get pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if: • symptoms persist for more than 48 hours • there is discharge from the ear • there is a fever of 102°F or greater Ask a doctor before use if you have: • ear drainage or discharge • pain, irritation, or rash in the ear • had ear surgery • dizziness

Reported adverse events (FAERS/openFDA)#

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