FDA label edb5015d-f063-5d1d-e053-2a95a90ab16d

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
59774c8a-deaf-53a6-e053-2991aa0a709f
SPL ID
edb5015d-f063-5d1d-e053-2a95a90ab16d
Version
4
Effective date
2022-11-17
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:14

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  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. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have  a breathing problem such as emphysema or chronic bronchitis  glaucoma  trouble urinating due to enlargement of the prostate gland  heart disease  high blood pressure  thyroid disease  diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product  excitability may occur, especially in children  may cause drowsiness  avoid alcoholic drinks  alcohol, sedatives, and tranquilizers may increase the drowsiness effect  use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if  nervousness, dizziness, or sleeplessness occur  symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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