FDA label 1c674517-16f4-4a90-90e3-a569d882acc3

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: 762577d4-1f15-4ab0-afbf-612fb8ad2f9f
SPL ID: 1c674517-16f4-4a90-90e3-a569d882acc3
Version: 8
Effective date: 2010-08-25
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:49:48

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		1c674517-16f4-4a90-90e3-a569d882acc3	id
spl set id		762577d4-1f15-4ab0-afbf-612fb8ad2f9f	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: - For external use only - A physician should be consulted about earache in children. - Initial exacerbation of symptoms may occur. - Keep this and all medicines out of the reach of children. - If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children Keep this and all medicines out of the reach of children

Reported adverse events (FAERS/openFDA)#

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