FDA label 292c5f0c-3b54-9de3-e063-6394a90a224d

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
5e1aff7d-41c0-4b39-8b0c-1a5aadda612d
SPL ID
292c5f0c-3b54-9de3-e063-6394a90a224d
Version
5
Effective date
2024-12-13
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:54:53

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 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 Doctor before use if you have cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product do not exceed recommended dosage do not use for more than 7 days Stop use and ask a doctor if cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use Keep Out of Reach of Children In case of accidental overdose, get medical help or contact a Poison Control Center right away. Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over: take 1 softgel every 4 hours children under 12 years of age: do not use

Reported adverse events (FAERS/openFDA)#

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