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: CVS Pharmacy, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e9161bb2-190f-14b3-e053-2995a90a9b2f
SPL ID: ca6c580e-a29b-4698-a226-bb8e3bdee26b
Version: 3
Effective date: 2024-06-01
Source export date: 2026-10-30
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/eb45a4bb6908a5d117668eac8da5ce490c753c3f9b68298758ef131307d1d264/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:17:10

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		CVS Pharmacy, Inc.	openfda.manufacturer_name
ndc	package	51316-007-84	openfda.package_ndc
ndc	package	51316-007-67	openfda.package_ndc
ndc	product	51316-007	openfda.product_ndc
ndc11	package	51316000784	derived:openfda.package_ndc
ndc11	package	51316000767	derived:openfda.package_ndc
rxcui		997406	openfda.rxcui
spl id		ca6c580e-a29b-4698-a226-bb8e3bdee26b	id
spl set id		e9161bb2-190f-14b3-e053-2995a90a9b2f	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.