FDA.reportPublic FDA data

CVS Fexofenadine Hydrochloride

Manufacturer
CVS Pharmacy
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:00

Label at a glance#

ProductCVS Fexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Dosage and administration

adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

 ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if printed safety seal under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregenatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-183-00CVS Fexofenadine Hydrochloride180 in 1 BOTTLETABLET1803

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-18351316-183-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
FERRIC OXIDE RED1K09F3G675IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2018-08-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1384e616aacf4f…
2026-08-18 06:07:402026-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133f01610625f2…
2019-09-15 20:21 UTC2019-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Pharmacy3d6c7b10-ed05-bbde-e063-6294a90ae92f2025-10-22WarningsExact identifier
ndc (package): 51316-183-00
ndc (product): 51316-183
ndc11 (package): 51316018300
spl id: 41c5bbff-5362-e7e2-e063-6294a90a5fc2
spl set id: 3d6c7b10-ed05-bbde-e063-6294a90ae92f

Reported adverse events (FAERS/openFDA)#

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