FDA label a4fbc4cf-d6cb-4fdf-97a8-be23c47a4a13

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: 1a435d76-109f-4a20-863e-8df64275bb79
SPL ID: a4fbc4cf-d6cb-4fdf-97a8-be23c47a4a13
Version: 2
Effective date: 2013-12-17
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:23:05

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		a4fbc4cf-d6cb-4fdf-97a8-be23c47a4a13	id
spl set id		1a435d76-109f-4a20-863e-8df64275bb79	set_id

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 a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough that occurs with too much phlegm (mucus)

Reported adverse events (FAERS/openFDA)#

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