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: 644dae51-7865-408c-a603-5eddffb90e53
SPL ID: 436b7cb6-bc72-4b51-986e-22ad631ce0a2
Version: 4
Effective date: 2024-09-03
Source export date: 2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:59

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	58602-833-17	openfda.package_ndc
ndc	package	58602-833-12	openfda.package_ndc
ndc	product	58602-833	openfda.product_ndc
ndc11	package	58602083312	derived:openfda.package_ndc
ndc11	package	58602083317	derived:openfda.package_ndc
rxcui		1305603	openfda.rxcui
spl id		436b7cb6-bc72-4b51-986e-22ad631ce0a2	id
spl set id		644dae51-7865-408c-a603-5eddffb90e53	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.