FDA.reportPublic FDA data

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

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)

Brand name
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Generic name
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
Manufacturer
OPMX LLC
Product type
HUMAN OTC DRUG
SPL set ID
8bb85b23-e9f6-48c7-84b0-15e0e26df4c5
SPL ID
352f8de3-8fcf-4098-e063-6294a90ace4d
Version
6
Effective date
2025-05-15
Source export date
2026-08-17
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/0b1cc8680154603ac269ec69e1c6611714d626104ff688eca4b2c067b511bd72/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:54:25
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema