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: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: bced0a2e-047e-456e-bbd2-495e83bf07ee
SPL ID: bced0a2e-047e-456e-bbd2-495e83bf07ee
Version: 1
Effective date: 2025-04-18
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:01

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	215232	derived:openfda.application_number
application number		ANDA215232	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		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-844-85	openfda.package_ndc
ndc	package	58602-844-66	openfda.package_ndc
ndc	package	58602-844-60	openfda.package_ndc
ndc	product	58602-844	openfda.product_ndc
ndc11	package	58602084460	derived:openfda.package_ndc
ndc11	package	58602084485	derived:openfda.package_ndc
ndc11	package	58602084466	derived:openfda.package_ndc
rxcui		997415	openfda.rxcui
spl id		bced0a2e-047e-456e-bbd2-495e83bf07ee	id
spl set id		bced0a2e-047e-456e-bbd2-495e83bf07ee	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.