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: 389230e5-775e-5b0d-e054-00144ff88e88
SPL ID: 41b5005a-2f6d-775b-e063-6294a90aa66e
Version: 9
Effective date: 2025-10-21
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:41

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	58657-505-08	openfda.package_ndc
ndc	product	58657-505	openfda.product_ndc
ndc11	package	58657050508	derived:openfda.package_ndc
rxcui		996520	openfda.rxcui
spl id		41b5005a-2f6d-775b-e063-6294a90aa66e	id
spl set id		389230e5-775e-5b0d-e054-00144ff88e88	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.