FDA label da947d56-e0f5-4f91-88bd-82990cd4a7c4

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
3434547a-6ef1-496f-93a2-e1c0539ebaaa
SPL ID
da947d56-e0f5-4f91-88bd-82990cd4a7c4
Version
1
Effective date
2013-11-11
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:58

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, 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 heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem, or persistent or chronic cough such as occurs with smoking, asthma, emphysema or chronic bronchitis cough accompanied by excessive phlegm (mucus) 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 Do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages. Stop use and ask a doctor if new symptoms occur nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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.