FDA label 1b72609e-465f-49ac-a459-c0f85274738f

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
a053a509-fa93-4929-bcba-5ccae9ffdda2
SPL ID
1b72609e-465f-49ac-a459-c0f85274738f
Version
3
Effective date
2020-04-07
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:08:06

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 giving this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease, high blood, pressure thyroid disease, diabetes, glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. If new symptoms reoccur

Reported adverse events (FAERS/openFDA)#

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