FDA label 67d0e4a6-91ac-4aac-bc2d-87cbc131529a

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: e5a21e5c-75c8-4ccd-8a3d-919ea0078063
SPL ID: 67d0e4a6-91ac-4aac-bc2d-87cbc131529a
Version: 1
Effective date: 2010-06-23
Source export date: 2026-11-06
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/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:49:29

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		67d0e4a6-91ac-4aac-bc2d-87cbc131529a	id
spl set id		e5a21e5c-75c8-4ccd-8a3d-919ea0078063	set_id

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 take by mouth. Earache drops are only to be used in the ears. Do not use with ear tubes. 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 If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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