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: WALGREEN CO.
Product type: HUMAN OTC DRUG
SPL set ID: cc1ac1b4-cbc4-539c-e053-2a95a90a5b75
SPL ID: d4c1a405-1f10-49fc-b85d-c452cf23347c
Version: 3
Effective date: 2023-12-01
Source export date: 2026-11-06
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/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:45:31

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		WALGREEN CO.	openfda.manufacturer_name
ndc	package	0363-9946-45	openfda.package_ndc
ndc	package	0363-9946-40	openfda.package_ndc
ndc	product	0363-9946	openfda.product_ndc
ndc11	package	00363994640	derived:openfda.package_ndc
ndc11	package	00363994645	derived:openfda.package_ndc
rxcui		1305603	openfda.rxcui
spl id		d4c1a405-1f10-49fc-b85d-c452cf23347c	id
spl set id		cc1ac1b4-cbc4-539c-e053-2a95a90a5b75	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.