FDA label e95ec98e-1a24-ddd9-e053-2a95a90af95e

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
9247ea9f-3df1-ef4c-e053-2995a90aab15
SPL ID
e95ec98e-1a24-ddd9-e053-2a95a90af95e
Version
4
Effective date
2022-09-23
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:49

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug. 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 _________________________________________________________________ Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________ Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

warnings

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug. 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 _________________________________________________________________ Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________ Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. you are hypersensitive to any of the ingredients ___________________________________________________________________ If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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