FDA label 64a83872-3f65-f025-e053-2991aa0ad36b

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
784843f7-2d13-4831-a50d-d109a371966d
SPL ID
64a83872-3f65-f025-e053-2991aa0ad36b
Version
2
Effective date
2018-02-07
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 02:33:02

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. Do not use this product <ul> <li>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.&nbsp; If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.<br /> &nbsp;</li> </ul> Ask a doctor before use if you have <ul> <li>a breathing problem such as emphysema or chronic bronchitis</li> <li>glaucoma</li> <li>trouble urinating due to an enlarged prostate gland</li> <li>a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema</li> <li>a cough that occurs with too much phlegm (mucus)</li> <li>heart disease</li> <li>high blood pressure</li> <li>thyroid disease</li> <li>diabetes mellitus<br /> &nbsp;</li> </ul> Ask a doctor or pharmacist before use if you are <p>taking sedatives or tranquilizers.<br /> &nbsp;</p> When using this product <ul> <li>excitability may occur, especially in children</li> <li>may cause marked drowsiness</li> <li>avoid alcoholic drinks</li> <li>alcohol, sedatives, and tranquilizers may increase drowsiness</li> <li>be careful when driving a motor vehicle or operating machinery<br /> &nbsp;</li> </ul> Stop use and ask a doctor if <p>taking sedatives or tranquilizers.<br /> &nbsp;</p> If pregnant or breast-feeding, <p>ask a health professional before use.<br /> &nbsp;</p> Keep out of the reach of children. <p>In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.<br /> &nbsp;</p>

Reported adverse events (FAERS/openFDA)#

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