FDA label fc11048e-b8dd-cde7-e053-6394a90a52e9

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
9c990987-1b08-6e9d-e053-2a95a90a2948
SPL ID
fc11048e-b8dd-cde7-e053-6394a90a52e9
Version
6
Effective date
2023-05-19
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 05:12:47

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: more than the recommended dosage. If drowsiness occurs, do not drive or operate machinery. if you are 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 chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. difficulty in urination due to enlargement of the prostate gland. glaucoma. thyroid disease. a cough that occurs with too much phlegm (mucus). Stop use and ask a doctor if cough lasts more than seven days, returns or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, Do Not Use. Keep out of reach of children. In case of accidental 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.