FDA.reportPublic FDA data

fexofenadine hcl

Manufacturer
Radha Pharmaceuticals | ScieGen Pharmaceuticals, Inc.
Effective date
2025-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:03

Label at a glance#

Productfexofenadine hcl
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure9 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

Directions (for 60mg) adults and children 12 years of age and over take one 60mg 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 Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take mo...

Storage and handling

store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg) this product meets the requirements of USP Dissolution Test 2

Label contents#

Full prescribing information#

ALLERGY Active ingredient (in each film-coated tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP 60 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

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

ask a health professional before use.

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

Directions (for 60mg)

adults and children 12 years of age and over

take one 60mg 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

Directions (for 180mg)

adults and children 12 years of age and over

take one 180mg 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

STORAGE AND HANDLING SECTION

  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

OTC - QUESTIONS SECTION

Questions or comments?

Call toll-free 1-855-724-3436
Distributed by: Radha Pharmaceuticals Inc
Hauppauge, NY 11788 USA

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Radha Pharmaceuticals Inc

NDC 77771-201-01

Compare to the
active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

60 mg

Antihistamine

12-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

100 Tablets

Allergy Relief

fexofenadine-allergy-60mg-100sfexofenadine-allergy-60mg-100s

Radha Pharmaceuticals Inc

NDC 77771-201-05

Compare to the
active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

60 mg

Antihistamine

12-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

500 Tablets

Allergy Relief

fexofenadine-allergy-60mg-500sfexofenadine-allergy-60mg-500s

Radha Pharmaceuticals Inc

NDC 77771-202-30

Compare to
the active ingredient in
Allegra ®Allergy *

Non-Drowsy

Fexofenadine
Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

30 Tablets

Allergy Relief

fexofenadine-allergy-180mg-30sfexofenadine-allergy-180mg-30s

Radha Pharmaceuticals Inc

NDC 77771-202-01

Compare to the active
ingredient in Allegra ®
Allergy 24 Hour Tablets *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

100 Tablets

Allergy Relief

fexofenadine-allergy-180mg-100sfexofenadine-allergy-180mg-100s

Radha Pharmaceuticals Inc

NDC 77771-202-05

Compare to the active
ingredient in Allegra ®
Allergy 24 Hour Tablets *

Non-Drowsy

Fexofenadine Hydrochloride
Tablets, USP

180 mg

Antihistamine

24-Hour

Indoor/Outdoor Allergy Relief

◾ Sneezing ◾ Runny Nose

◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat

500 Tablets

Allergy Relief

fexofenadine-allergy-180mg-500sfexofenadine-allergy-180mg-500s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1
997501fexofenadine HCl 60 MG Oral TabletPSN1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1
997501fexofenadine hydrochloride 60 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77771-201-01fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1001
77771-201-05fexofenadine hcl500 in 1 BOTTLETABLET, FILM COATED5001
77771-202-01fexofenadine hcl100 in 1 BOTTLETABLET, FILM COATED1001
77771-202-05fexofenadine hcl500 in 1 BOTTLETABLET, FILM COATED5001
77771-202-30fexofenadine hcl30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-201FEXOFENADINE HCL TABLET, FILM COATED [RADHA PHARMACEUTICALS]1Current NDC, 2 package rows20250315_30283df1-6394-3a91-e063-6394a90a6776.zip
77771-202FEXOFENADINE HCL TABLET, FILM COATED [RADHA PHARMACEUTICALS]1Current NDC, 3 package rows20250315_30283df1-6394-3a91-e063-6394a90a6776.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-201-01EA - Each77771-201a69d380b-466f-46a9-b177-b028b747c8f512025-05-14
77771-201-05EA - Each77771-201ccee194e-9bff-45a0-8c83-3358cab9f00912025-05-14
77771-202-01EA - Each77771-202e171dc96-436e-4aa6-9189-1f74fa06868f12025-05-14
77771-202-05EA - Each77771-202c928af5e-11a1-4a13-b8b6-c275b120673712025-05-14
77771-202-30EA - Each77771-20229d6e099-3fe7-4342-ac9a-ccc8a0a3a0b412025-05-14

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
77771-20177771-201-01, 77771-201-05
77771-20277771-202-30, 77771-202-01, 77771-202-05

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
ANHYDROUS LACTOSE3SY5LH9PMKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
ANHYDROUS LACTOSE3SY5LH9PMKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STEARIC ACID4ELV7Z65APIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-08-18 06:07:402026-07A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-165bbf6a4d5a75…

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
fexofenadine hclFEXOFENADINE HCLRadha Pharmaceuticals30283df1-6394-3a91-e063-6394a90a67762025-03-10WarningsExact identifier
ndc (package): 77771-201-05
ndc (package): 77771-202-01
ndc (package): 77771-202-05
ndc (package): 77771-202-30
ndc (package): 77771-201-01
ndc (product): 77771-202
ndc (product): 77771-201
ndc11 (package): 77771020105
ndc11 (package): 77771020201
ndc11 (package): 77771020101
ndc11 (package): 77771020230
ndc11 (package): 77771020205
spl id: 302845c7-2356-3b13-e063-6394a90a0e26
spl set id: 30283df1-6394-3a91-e063-6394a90a6776

Reported adverse events (FAERS/openFDA)#

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