CVS Fexofenadine 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: CVS Fexofenadine Hydrochloride
Generic name: FEXOFENADINE HYDROCHLORIDE
Manufacturer: CVS Pharmacy
Product type: HUMAN OTC DRUG
SPL set ID: 3d6c7b10-ed05-bbde-e063-6294a90ae92f
SPL ID: 41c5bbff-5362-e7e2-e063-6294a90a5fc2
Version: 3
Effective date: 2025-10-22
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:38:17

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	210137	derived:openfda.application_number
application number		ANDA210137	openfda.application_number
brand name		CVS Fexofenadine Hydrochloride	openfda.brand_name
generic name		FEXOFENADINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		CVS Pharmacy	openfda.manufacturer_name
ndc	package	51316-183-00	openfda.package_ndc
ndc	product	51316-183	openfda.product_ndc
ndc11	package	51316018300	derived:openfda.package_ndc
rxcui		997420	openfda.rxcui
spl id		41c5bbff-5362-e7e2-e063-6294a90a5fc2	id
spl set id		3d6c7b10-ed05-bbde-e063-6294a90ae92f	set_id
unii		2S068B75ZU	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 Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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