FDA label 0bc94e0e-6767-425e-e063-6394a90a6bf1

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
f069a80f-1320-4260-b5d7-c9e58b419d04
SPL ID
0bc94e0e-6767-425e-e063-6394a90a6bf1
Version
4
Effective date
2023-12-05
Source export date
2026-11-06
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:04:47

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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product. • more than the recommended dose. Stop use and ask a doctor if: • symptoms do not improve within 7 days or are accompanied by fever. • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These can be signs of a serious condition. Ask a doctor before use if you have: • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

Reported adverse events (FAERS/openFDA)#

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