FDA label ec8ad36b-66b4-8820-e053-2995a90ad76d

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
ca13b8c2-022b-4eab-a573-8e4a65e33130
SPL ID
ec8ad36b-66b4-8820-e053-2995a90ad76d
Version
1
Effective date
2022-11-03
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 05:39:20

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 taking this product. Do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis. glaucoma. a persistent or chronic cough that occurs with too much phlegm (mucus). heart disease. high blood pressure. thyroid disease. diabetes mellitus. difficulty in urination due to enlargement of the prostate gland. 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. sedatives and tranquilizers may increase drowsiness effect. 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. new symptoms occur. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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