FDA label b2a35e32-16b4-4159-971a-86443a258fc4

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
3bc896f1-f10d-51b1-e054-00144ff8d46c
SPL ID
b2a35e32-16b4-4159-971a-86443a258fc4
Version
3
Effective date
2019-11-18
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:55

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 use ▪ 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. ▪ in children under 6 years of age Ask a doctor before use if you have ▪ high blood pressure, heart disease, diabetes, or thyroid disease ▪ difficulty in urination due to enlargement of the prostate gland ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ a sodium-restricted diet Ask a doctor or pharmacist before use if you are ▪ taking any other oral nasal decongestant or stimulant ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ use caution when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children Stop use and ask a doctor if ▪ symptoms do not improve within 7 days or are accompanied by fever ▪ new symptoms occur ▪ nervousness, dizziness, or sleeplessness occurs 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.