FDA label 2b547eaf-e879-82bd-e063-6294a90a9ac5

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
cc353280-0b4c-418c-93fe-850125955009
SPL ID
2b547eaf-e879-82bd-e063-6294a90a9ac5
Version
6
Effective date
2025-01-09
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:15:23

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 ​ Enter section text here 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 contains an MAOI, ask a doctor or pharmacist before taking this priduct. Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■difficulty in urination due to enlargement of the prostate Ask a doctor or pharmacist before use ■ if you are taking sedatives or tranquilizers When using this product ■ do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. ■ you may get drowsy. ■ may cause excitability, especially in children. ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect. ■ avoid alcoholic beverages. ■ use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if ■ symptoms do not improve within seven days ■ symptoms are accompanied by fever