Guaifenesin and Pseudoephedrine HCl

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 Pseudoephedrine HCl
Generic name: GUAIFENESIN AND PSEUDOEPHEDRINE HCL
Manufacturer: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 2f622f57-4de0-44a9-a21f-c98260574f1e
SPL ID: 2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb
Version: 4
Effective date: 2024-09-03
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:29:48

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	213203	derived:openfda.application_number
application number		ANDA213203	openfda.application_number
brand name		Guaifenesin and Pseudoephedrine HCl	openfda.brand_name
generic name		GUAIFENESIN AND PSEUDOEPHEDRINE HCL	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-834-78	openfda.package_ndc
ndc	package	58602-834-77	openfda.package_ndc
ndc	product	58602-834	openfda.product_ndc
ndc11	package	58602083477	derived:openfda.package_ndc
ndc11	package	58602083478	derived:openfda.package_ndc
rxcui		1244675	openfda.rxcui
spl id		2fb64af9-47fb-442a-b7ee-8aae3d5b0ddb	id
spl set id		2f622f57-4de0-44a9-a21f-c98260574f1e	set_id
unii		6V9V2RYJ8N	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.