FDA label ff239cc9-2d2c-4eeb-ab96-7c32040447d7

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
171fe7a3-bdc4-44d3-a778-f600ad167f1b
SPL ID
ff239cc9-2d2c-4eeb-ab96-7c32040447d7
Version
2
Effective date
2025-04-24
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 06:19:16

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 (MAIO) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons Disease), or for 2 weeks after stopping the MAIO drug. If you are uncertain whether your prescription drug contains an MAIO, ask a health professional. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • excessive phlegm (mucus) • difficulty in urination due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occurs • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus) • cough and congestion do not approve within 7 days or tend to recur. These could be signs of a serious condition. If pregnancy or breast-feeding, ask a health professional before use. Keep out of the 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.