Fexofenadine HCl Tablets USP

Manufacturer
Family Dollar Stores, Inc.
Effective date
2020-02-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:32

Label at a glance#

ProductAllergy Relief
Active ingredientFexofenadine Hydrochloride
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing 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#

20171207

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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 respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

WARNINGS SECTION

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 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 individual blister units are torn or opened
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-888-375-3784

Allergy Relief (fexofenadine hydrochloride USP) Tablets 180 mg 15 count carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT OF ALLREGRA® ALLERGY 24 HOUR TABLETS*

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Original Prescription Strength
NON-DROWSY

Allergy Relief
Fexofenadine Hydrochloride Tablets USP,
180mg / Antihistamine

Indoor & Outdoor Allergies
Relief of:
Sneezing; Runny Nose
Itchy, Watery Eyes; Itchy Nose or Throat

15 TABLETS 180 mg each

24 HOUR

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN4
997420fexofenadine hydrochloride 180 MG Oral TabletSCD4
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY4

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
55319-917-15Allergy Relief5 in 1 BLISTER PACKTABLET54
55319-917-15Allergy Relief3 in 1 CARTONTABLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-917ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [FAMILY DOLLAR STORES, INC. ]4Current NDC, Legacy NDC, 2 package rows20231009_f532e9d5-6457-8bef-e83e-16050f20b03c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-784-01EA - Each55111-784fcfbe779-dfaf-4c1a-b197-12b0a5ca524712018-12-13
55111-784-30EA - Each55111-7849ca6ce31-a274-408f-b03e-0b74b74bc4fd12015-09-10

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
55319-91755319-917-15
55111-784

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
A076502-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11
A076502-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11
A076502-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11
A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12
A076502-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12

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 22:38:342026-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-09-14 22:38:342026-08A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1284e616aacf4f…
2026-08-18 06:07:402026-07A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-007FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-009FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2011-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001FEXOFENADINE HYDROCHLORIDE30MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORALAB2006-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2011-04-126a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076502-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076502-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076502-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076502-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076502-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076502-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076502-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076502-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076502-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076502-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076502-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076502-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076502-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076502-001AB18072bd15b7f6…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsExact identifier
ndc (product): 55111-784
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFamily Dollar Stores, Inc.f532e9d5-6457-8bef-e83e-16050f20b03c2020-02-19WarningsExact identifier
ndc (package): 55319-917-15
ndc (product): 55319-917
ndc11 (package): 55319091715
spl id: 706ad449-ef0a-6212-7f56-8fcb3dc9e3a1
spl set id: f532e9d5-6457-8bef-e83e-16050f20b03c

Reported adverse events (FAERS/openFDA)#

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