FDA label 3af2378b-5e71-45e4-a66e-86ea852a720f

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
aee0c48f-66da-487e-9b12-aef57559b726
SPL ID
3af2378b-5e71-45e4-a66e-86ea852a720f
Version
2
Effective date
2017-01-25
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:36:52

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 heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms are accompanied by a persistent cough for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache if symptoms do not improve within 7 days or accompanied by a fever — 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 immediately.

Reported adverse events (FAERS/openFDA)#

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