FDA label 983d5ba4-d9aa-43a8-a9f5-64a2f2ae05ff

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: 3fb0eac7-73dd-400f-b463-ce7abdcf3c3d
SPL ID: 983d5ba4-d9aa-43a8-a9f5-64a2f2ae05ff
Version: 2
Effective date: 2020-04-07
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 05:51:30

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		983d5ba4-d9aa-43a8-a9f5-64a2f2ae05ff	id
spl set id		3fb0eac7-73dd-400f-b463-ce7abdcf3c3d	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 the child has a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if the child is taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if new symptoms occur. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.

Reported adverse events (FAERS/openFDA)#

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