FDA.reportPublic FDA data

Fexofenadine hydrochloride

Manufacturer
Walgreen CO | Aurolife Pharma, LLC
Effective date
2019-09-10
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:15

Label at a glance#

ProductFexofenadine hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper resporatory allergies: runny nose sneezing  itchy, watery eyes 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 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 ...

Label contents#

Full prescribing information#

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION


Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg

Purpose

OTC - PURPOSE SECTION


Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper resporatory allergies:

  • runny nose
  • sneezing
  •  itchy, watery eyes
  • 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 aluminium or magnesium antacids
  • do not take with fruit juices (see directions)

Stop use and ask 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.

Directions

DOSAGE & ADMINISTRATION SECTION


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


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



Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

SPL UNCLASSIFIED SECTION

 call 1-855-274-4122

Principal Display Panel- 60 mg 24 ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-0095-24
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
12 HOUR ALLERGY
Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
12 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
24 Tablets 60 mg each
walfex-fig1walfex-fig1

Principal Display Panel- 180 mg 15 ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 0363-0097-53
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
24 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
15 Tablets 180 mg each
Walfex-fig2Walfex-fig2




DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3
997501fexofenadine HCl 60 MG Oral TabletPSN3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3
997501fexofenadine hydrochloride 60 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0095-242023-01-30C16284748780-1f386c649-cce1-0266-e053-dadaa90a7c1add7a5c55-f834-4aa2-8cdf-a62154ce7dde
0363-0097-532023-01-30C16284748780-1f386c649-cce1-0266-e053-dadaa90a7c1add7a5c55-f834-4aa2-8cdf-a62154ce7dde
0363-0097-552023-01-30C16284748780-1f386c649-cce1-0266-e053-dadaa90a7c1add7a5c55-f834-4aa2-8cdf-a62154ce7dde

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0095-24Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
0363-0095-24Fexofenadine hydrochloride24 in 1 BLISTER PACKTABLET, FILM COATED243
0363-0097-53Fexofenadine hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED153
0363-0097-53Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
0363-0097-55Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
0363-0097-55Fexofenadine hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0095FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [WALGREEN CO]3Legacy NDC, 2 package rows20190911_dd7a5c55-f834-4aa2-8cdf-a62154ce7dde.zip
0363-0097FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [WALGREEN CO]3Legacy NDC, 4 package rows20190911_dd7a5c55-f834-4aa2-8cdf-a62154ce7dde.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-00950363-0095-24
0363-00970363-0097-55, 0363-0097-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2014-11-19
A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2014-11-19
A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2014-11-19

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1984e616aacf4f…
2026-09-14 22:38:342026-08A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1984e616aacf4f…
2026-09-14 22:38:342026-08A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1984e616aacf4f…
2026-08-18 06:07:402026-07A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202039-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2014-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202039-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2014-11-19301d65b070ca…

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
45b3aac8-2ad2-4cfa-858e-9cb8528292e6dd7a5c55-f834-4aa2-8cdf-a62154ce7dde2019-09-10WarningsExact identifier
spl id: 45b3aac8-2ad2-4cfa-858e-9cb8528292e6
spl set id: dd7a5c55-f834-4aa2-8cdf-a62154ce7dde

Reported adverse events (FAERS/openFDA)#

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