Home FDA labels e516a156-209d-4f69-8ebc-9a53e8d98f20 FDA label e516a156-209d-4f69-8ebc-9a53e8d98f20 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 a478f60c-b556-45f2-8c0d-b7b73c8943b2
SPL ID e516a156-209d-4f69-8ebc-9a53e8d98f20
Version 1
Effective date 2010-08-12
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:47:51 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.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.