FDA label 62778a3c-0ed9-2d0d-e053-2a91aa0a09c9

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: 2bd85bda-978c-4b51-8dd3-05093b7be4ad
SPL ID: 62778a3c-0ed9-2d0d-e053-2a91aa0a09c9
Version: 3
Effective date: 2018-01-10
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 05:51:02

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		62778a3c-0ed9-2d0d-e053-2a91aa0a09c9	id
spl set id		2bd85bda-978c-4b51-8dd3-05093b7be4ad	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 exceed recommended dosage. Ask a doctor before use if your child has a breathing problem such as chronic bronchitis glaucoma Ask the child's doctor before use if the child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase drowsiness effect Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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