FDA label 0e0bfaf5-9e63-5821-e063-6294a90a7e1f

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
c6b31cfd-a576-1436-e053-2995a90acca4
SPL ID
0e0bfaf5-9e63-5821-e063-6294a90a7e1f
Version
5
Effective date
2024-01-03
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:19

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 use ■ 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 ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ a cough that is accompanied by excessive phlegm (mucus) ■ a persistent orchronic cough as occurs with smoking, asthma or emphysema ■ trouble urinating due toenlarged prostate gland Stop Use and ask a Doctor if ■ a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. ■ new symptoms occur ■ nervousness, dizziness, or sleeplessness occur If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental 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.