FDA label f75d1e41-3e3a-440a-9768-4bfb71d7668d

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
daf47021-cf49-4d6f-9dbf-2d0a69da4c9c
SPL ID
f75d1e41-3e3a-440a-9768-4bfb71d7668d
Version
1
Effective date
2020-06-23
Source export date
2026-11-06
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:59:55

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 mellitus 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 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 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.