FDA label 47d40763-f19b-a5df-e063-6394a90af7bd

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
f66a4235-d1a5-d2fa-e053-2a95a90a67f9
SPL ID
47d40763-f19b-a5df-e063-6394a90af7bd
Version
4
Effective date
2026-01-07
Source export date
2026-11-06
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/90742968499056f8845d54427ea2950526b02c3f289aedd40679ed8e120a0e89/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:45:03

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 ■ glaucoma ■ trouble urinating due to an enlarged prostate Ask a doctor before use if the child is taking sedatives or tranquilizers When using this product ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ sedatives and tranquilizers may increase the drowsiness effect Stop use and ask a doctor if ■ new symptoms occur Keep out of 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.