FDA label fba5174b-c137-4448-a71d-c45e00f9deb2

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
e3f295cb-7708-4d20-bf43-38565313383a
SPL ID
fba5174b-c137-4448-a71d-c45e00f9deb2
Version
1
Effective date
2023-04-04
Source export date
2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:18

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 c hildren. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222 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.