FDA label 472e27dc-944c-73bf-e063-6294a90a21b9

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
82f9f52c-797e-4842-9c9a-40213181d99a
SPL ID
472e27dc-944c-73bf-e063-6294a90a21b9
Version
8
Effective date
2025-12-30
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:26:43

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: Ask a doctor before you use if you are taking sedatives or tranquilizers. Ask your doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma difficulty in urination due to the enlargement of the prostate gland. When using this product do not exceed the recommended dosage excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask doctor if nervousness, dizziness or sleepiness occur symptoms do not improve withing 7 days or occur with a fever

Reported adverse events (FAERS/openFDA)#

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