FDA.reportPublic FDA data

FDA label f14d2229-6671-4f15-aeb8-ace34ea3a0ea

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
93c79ca2-866b-4453-aebc-7b887301b6ad
SPL ID
f14d2229-6671-4f15-aeb8-ace34ea3a0ea
Version
2
Effective date
2014-01-20
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:20:13

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 have heart disease, high blood pressure, thyroid disease, diabetes, or difficult in urination due to an enlarged prostate gland unless directed by a doctor * if you are taking 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 * for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm unless directed by a doctor

Reported adverse events (FAERS/openFDA)#

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