FDA label ea2e192a-db23-4a42-aef7-45161d4cf48f

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
8d7bcf9e-89af-45a2-84f8-d000eb399c99
SPL ID
ea2e192a-db23-4a42-aef7-45161d4cf48f
Version
4
Effective date
2018-02-21
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:31:01

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 breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to an enlargement of the 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 Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product excitability may occur, especially in children may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving motor vehicles or operating machinary

Reported adverse events (FAERS/openFDA)#

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