FDA.reportPublic FDA data

Fexofenadine Hydrochloride Tablets USP

Manufacturer
AvPAK
Effective date
2018-03-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:00:31

Label at a glance#

ProductFexofenadine hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 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 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



For 180 mg:

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

Warnings

WARNINGS SECTION

Do not use 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 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 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, stearic acid, titanium dioxide, and yellow iron oxide

Questions?

SPL UNCLASSIFIED SECTION


Call 1-855-361-3993



Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-316-15
Fexofenadine Hydrochloride Tablets USP
Antihistamine
180 mg
50 Tablets (5 X 10) Unit Dose

5026831615       

NDC 50268-316-15
Fexofenadine Hydrochloride Tablets USP
Antihistamine
180 mg
50 Tablets (5 X 10) Unit Dose

5026831615            

label 1
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label 2
label 2
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label 3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-316-11EA - Each50268-316867bafd0-b851-47eb-b705-85236a68854f12016-09-02
50268-316-15EA - Each50268-316c6599943-bbca-48b7-8363-5467606a2f4812016-09-02
13107-067-05EA - Each13107-06798471e35-364d-4ca0-9bb5-26e456c6f7cc12015-06-09

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
50268-31650268-316-11, 50268-316-15
13107-067

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
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

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
6891f74f-8160-dc20-e053-2a91aa0af588d15dbbc5-b41f-876c-2ed4-4a227d9ed1d72018-03-29WarningsExact identifier
spl id: 6891f74f-8160-dc20-e053-2a91aa0af588
spl set id: d15dbbc5-b41f-876c-2ed4-4a227d9ed1d7

Reported adverse events (FAERS/openFDA)#

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