FDA label 50f3aea0-dbb8-413c-9d44-b4a0c8205808

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
796150ee-d59b-4af2-ad10-d82c083807ea
SPL ID
50f3aea0-dbb8-413c-9d44-b4a0c8205808
Version
2
Effective date
2019-05-28
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:29

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 trouble urinating due to an enlarged prostate gland Do not take if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Do not use to make a child sleepy If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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