FDA label 32d972ad-555a-e662-e063-6294a90afb3b

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: 7a7facbe-f245-d991-e053-2a91aa0aa26f
SPL ID: 32d972ad-555a-e662-e063-6294a90afb3b
Version: 3
Effective date: 2025-04-15
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:54:04

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		32d972ad-555a-e662-e063-6294a90afb3b	id
spl set id		7a7facbe-f245-d991-e053-2a91aa0aa26f	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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if symptoms persist for more than 48 hours or worsen.  discharge from ear is present.  symptoms are accompanied by a high fever (over 101ºF). Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use if imprinted tamper-evident bottle cap band is broken or missing. The inner packaged bottle is child resistant. In case of emergency Contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Reported adverse events (FAERS/openFDA)#

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