Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

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: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Generic name: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer: WALGREEN CO.
Product type: HUMAN OTC DRUG
SPL set ID: 1fcb601c-19d2-4db9-938b-b4f98ba9332f
SPL ID: d801f20e-2ed8-4758-8473-02a7727c4dd1
Version: 8
Effective date: 2024-06-26
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:23:49

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	209116	derived:openfda.application_number
application number		ANDA209116	openfda.application_number
brand name		Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride	openfda.brand_name
generic name		FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		WALGREEN CO.	openfda.manufacturer_name
ndc	package	0363-0094-67	openfda.package_ndc
ndc	package	0363-0094-84	openfda.package_ndc
ndc	product	0363-0094	openfda.product_ndc
ndc11	package	00363009484	derived:openfda.package_ndc
ndc11	package	00363009467	derived:openfda.package_ndc
rxcui		997406	openfda.rxcui
spl id		d801f20e-2ed8-4758-8473-02a7727c4dd1	id
spl set id		1fcb601c-19d2-4db9-938b-b4f98ba9332f	set_id
unii		2S068B75ZU	openfda.unii
unii		6V9V2RYJ8N	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 have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing

Reported adverse events (FAERS/openFDA)#

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