FDA label 27ad9197-a9d2-4c29-8b6f-e62de870cb24

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
9250c587-1a02-418b-9f3f-31e9fe00fc5f
SPL ID
27ad9197-a9d2-4c29-8b6f-e62de870cb24
Version
11
Effective date
2019-02-11
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:35:11

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 prostate gland Ask a doctor or pharmacist before use if you are • giving this product to children under 12 years of age • taking sedatives or tranquilizers When using this product • you may get drowsy • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. 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.