Guaifenesin and Dextromethorphan Hydrobromide

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: Guaifenesin and Dextromethorphan Hydrobromide
Generic name: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer: Method Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 1538bf63-d020-3ba2-e063-6294a90aecc5
SPL ID: 41b4eb73-e463-24b0-e063-6394a90a6cc0
Version: 3
Effective date: 2025-10-21
Source export date: 2026-10-27
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:05:42

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Guaifenesin and Dextromethorphan Hydrobromide	openfda.brand_name
generic name		GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	openfda.generic_name
manufacturer name		Method Pharmaceuticals	openfda.manufacturer_name
ndc	package	58657-504-08	openfda.package_ndc
ndc	product	58657-504	openfda.product_ndc
ndc11	package	58657050408	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		41b4eb73-e463-24b0-e063-6394a90a6cc0	id
spl set id		1538bf63-d020-3ba2-e063-6294a90aecc5	set_id
unii		9D2RTI9KYH	openfda.unii
unii		495W7451VQ	openfda.unii

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.

Reported adverse events (FAERS/openFDA)#

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