FDA.reportPublic FDA data

FDA label 5df4e8e0-4bec-7690-e053-2a91aa0aa076

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
4cdbecbe-3219-4083-adc0-5479dc3ad3b9
SPL ID
5df4e8e0-4bec-7690-e053-2a91aa0aa076
Version
2
Effective date
2017-11-14
Source export date
2026-08-01
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/2026-08-01/f23e8214fa581dc87bce024b3f15739356a8bb6f9298e3d6be38c21c662a4211/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:05:54

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 use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostrate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery. If Pregnant or breast-feeding, ask a health professional before use.