FDA label 7b31b0e7-ff51-4b0f-8ee0-aa78e6d676d0

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
47258c11-ddd8-4ce1-83a4-6fb5295c73aa
SPL ID
7b31b0e7-ff51-4b0f-8ee0-aa78e6d676d0
Version
3
Effective date
2021-04-22
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:05

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. Children under 2 years of age should be seen by a physician. • 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 the child has: • 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.