FDA.reportPublic FDA data

Fexofenadine hydrochloride

Manufacturer
Ahold U.S.A., Inc | Aurolife Pharma, LLC
Effective date
2019-09-11
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-05-31 23:00:15

Label at a glance#

ProductFexofenadine hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure17 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

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 resporatory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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 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 carton is opened or if printed foil inner seal on bottle is torn or missing
  • 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 (180 mg 15 ct)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 60000-409-53

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat

fexo10mg15ct.jpgfexo10mg15ct.jpg

Principal Display Panel (180 mg 30 ct)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 60000-409-30

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat
fexo180mg30ct.jpgfexo180mg30ct.jpg

Principal Display Panel (180 mg 45 ct)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 60000-409-45

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat

fexo180mg45ct.jpgfexo180mg45ct.jpg

Principal Display Panel (180 mg 45 ct+ 50% bonus)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 60000-409-48

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat
fexo180mg45ctbonus.jpgfexo180mg45ctbonus.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2

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
60000-409-302023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-452023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-482023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4
60000-409-532023-01-30C16284748780-1f386c64a-0a94-0266-e053-dadaa90a7c1ace7e5fc4-630a-4184-a7a8-9d877bfbadc4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60000-409-30Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-30Fexofenadine hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
60000-409-45Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-45Fexofenadine hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
60000-409-48Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-48Fexofenadine hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
60000-409-53Fexofenadine hydrochloride1 in 1 CARTONTABLET, FILM COATED12
60000-409-53Fexofenadine hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60000-409FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AHOLD U.S.A., INC]2Legacy NDC, 8 package rows20190911_ce7e5fc4-630a-4184-a7a8-9d877bfbadc4.zip

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
60000-40960000-409-48, 60000-409-30, 60000-409-53, 60000-409-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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

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
df192c93-2573-457f-9583-f94557ed028ece7e5fc4-630a-4184-a7a8-9d877bfbadc42019-09-11WarningsExact identifier
spl id: df192c93-2573-457f-9583-f94557ed028e
spl set id: ce7e5fc4-630a-4184-a7a8-9d877bfbadc4

Reported adverse events (FAERS/openFDA)#

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