FDA label 9a2e844b-6da4-48c3-a1ff-660dfd6453ae

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
fbe5ce15-b264-4fbc-a198-44ef14a676cd
SPL ID
9a2e844b-6da4-48c3-a1ff-660dfd6453ae
Version
3
Effective date
2018-02-21
Source export date
2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:50:33

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 the 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 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 cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistant headache. A persistant cough may be a sign of a serious condition New symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of 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.