FDA.reportPublic FDA data

Fexofenadine Hydrochloride

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC | Golden State Medical Supply, Inc.
Effective date
2017-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:13

Label at a glance#

ProductFexofenadine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 hydrochloride USP, 60 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
  • 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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

  • Tamper Evident: do not use if foil seal under cap is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Marketed/ Packaged by: GSMS, Inc., Camarillo, CA 93012 USA

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count180 mg
3043353-760-30
6043353-760-53
90XXXXX-XXX-60
120XXXXX-XXX-70
180XXXXX-XXX-80
240XXXXX-XXX-90
270XXXXX-XXX-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20171201JH

PRINCIPAL DISPLAY PANEL - 180mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43353-760 - Fexofenadine HCl 180mg - Rx Only
Bottle Label 180mgBottle Label 180mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1

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
43353-760-532020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts
43353-760-602020-01-31C16284748780-19d75b9d0-9b1d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-760-53Fexofenadine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
43353-760-60Fexofenadine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-760FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20171205_d0a79081-71e0-407d-876b-f4393fd4d1e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-760-60EA - Each43353-760a494b8e8-82f5-46f1-ad3f-2566270ee2e112018-02-20
60429-389-01EA - Each60429-389b61057e1-ca0d-46c2-804e-170a7abce92b12015-09-10
60429-389-05EA - Each60429-389ec41afbe-52c1-46f9-bf90-04e0e93eca3f12015-09-10

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43353-76043353-760-53, 43353-760-60
60429-389

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077081-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16
A077081-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11
A077081-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11
A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-07-21
A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-07-21
A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21
A077081-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-07-21

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 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-1684e616aacf4f…
2026-09-14 22:38:342026-08A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2007-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2008-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2007-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-002FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2008-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-07-216a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077081-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077081-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077081-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077081-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077081-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077081-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077081-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077081-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077081-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077081-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077081-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077081-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077081-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077081-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077081-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077081-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077081-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077081-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077081-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077081-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077081-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077081-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077081-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077081-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077081-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077081-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077081-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077081-003AB1782e0a99824c…

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
3b6da186-33ef-4a85-90df-f008a31ab498d0a79081-71e0-407d-876b-f4393fd4d1e52017-12-01WarningsExact identifier
spl id: 3b6da186-33ef-4a85-90df-f008a31ab498
spl set id: d0a79081-71e0-407d-876b-f4393fd4d1e5

Reported adverse events (FAERS/openFDA)#

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