FDA label ec8e1b86-9fd7-2534-e053-2a95a90a8bb3

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
fe6514a8-353f-4af4-89e7-1e6493f50224
SPL ID
ec8e1b86-9fd7-2534-e053-2a95a90a8bb3
Version
1
Effective date
2022-11-03
Source export date
2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:56

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. 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 mellilus ■ difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist 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 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 ■ symptoms do not improve within 7 days or are accompanied by a fever ■ new symptoms occur If pregnant or breast-feeding , 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.