FDA.reportPublic FDA data

Fexofenadine 60mg CPC

Manufacturer
YYBA Corp
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-01 05:10:13

Label at a glance#

ProductFexofenadine
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other 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 HCl 60mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

Do not use if you ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before using 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 healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

  • store between 20 and 25 degrees celcius (68-77 farenheit)
  • protect from excessive moisture
  • FDA approved dissolution specifications differ from the USP.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, Ferric Oxide Red, Ferric Oxide Yellow, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Povidone, Titanium Dioxide.

Questions of comments?

OTC - QUESTIONS SECTION

1-866-933-6337

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581000272GTIN-13: 0373581000272
EAN-13: 0373581000272
GTIN-12: 373581000272
UPC-A: 373581000272
GTIN storage (14 digits): 00373581000272		Screenshot 2026-07-27 142846.jpg

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
73581-01273581-012-01, 73581-012-06, 73581-012-02

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219032-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-28
A219032-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-2884e616aacf4f…
2026-09-14 22:38:342026-08A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219032-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2025-02-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219032-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2025-02-28a50c72e98297…

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
FexofenadineFEXOFENADINEYYBA Corp579c7ff9-0c44-1d46-e063-6294a90aef342026-07-27WarningsExact identifier
ndc (package): 73581-012-01
ndc (package): 73581-012-02
ndc (package): 73581-012-06
ndc (product): 73581-012
ndc11 (package): 73581001201
ndc11 (package): 73581001206
ndc11 (package): 73581001202
spl id: 579c7ff9-0c45-1d46-e063-6294a90aef34
spl set id: 579c7ff9-0c44-1d46-e063-6294a90aef34

Reported adverse events (FAERS/openFDA)#

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