FDA label b7878548-5ea2-41a5-92c7-a3b2d37feac5

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
fd6ab993-d4ca-490b-a07c-61b0910ea657
SPL ID
b7878548-5ea2-41a5-92c7-a3b2d37feac5
Version
3
Effective date
2021-01-30
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:46

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 you prescription drug contains an MAOI ask a doctor or pharmacist before taking this product. Do not use for more than 3 days. Use only as directed. Frequent for prolonged use may cause nasal congestion to recur or worsen. Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlargement of the prostate gland, or if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma. 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 avoid alcoholic drinks alcohol, sedative and tranquilizers may increase the drowsiness effect 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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