FDA label c792f1dc-b2e2-4302-8aac-faa9b172b4eb

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
c34db113-602a-452e-a243-5d3786db14ec
SPL ID
c792f1dc-b2e2-4302-8aac-faa9b172b4eb
Version
1
Effective date
2023-10-27
Source export date
2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:37:42

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 • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric 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 your doctor or pharmacist before taking this product. • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor. • Avoid alcoholic beverages while you taking this product. Ask the doctor before use if you have • Cough that occurs with too much phlegm (mucus) • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. Stop use and ask the doctor if • Nervousness, dizziness or sleeplessness occurs. • Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign 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 right away.

Reported adverse events (FAERS/openFDA)#

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