FDA label 9aa350d6-258d-43d8-e053-2995a90a824a

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: 89642356-6b67-4499-bcb8-4b54e83fe7e8
SPL ID: 9aa350d6-258d-43d8-e053-2995a90a824a
Version: 2
Effective date: 2019-12-26
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:59

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		9aa350d6-258d-43d8-e053-2995a90a824a	id
spl set id		89642356-6b67-4499-bcb8-4b54e83fe7e8	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 use if you have an allergy or hypersensitivity to components of the formula Ask a doctor before use if the child is under a doctor's care for any serious condition taking any other drug Stop use and ask a doctor if condition worsens symptoms persist for more than 15 days or clear up and occur again within a few days If pregnant or breast feeding ask a health care professional before use Keep out of the reach of children. In case of overdose, 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.