allergy relief

Manufacturer
Publix Super Markets Inc
Effective date
2022-01-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:48

Label at a glance#

Productallergy relief
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure8 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

Storage and handling

• do not use if printed blister unit is broken or torn • store between 68° -77°F (20° -25°C) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 2

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 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 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 (1-800-222-1222).

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 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

  • do not use if printed blister unit is broken or torn
  • store between 68° -77°F (20° -25°C)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P

24-HR

allergy relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

ANTIHISTAMINE

Indoor/outdoor allergy relief

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy nose or throat

NON-DROWSY

ACTUAL SIZE

15 TABLETS

Compare to Allegra® Allergy active ingredient

allergy relief image
allergy relief image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN2
997420fexofenadine hydrochloride 180 MG Oral TabletSCD2
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY2

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
56062-847-22allergy relief15 in 1 CARTONTABLET, FILM COATED152
56062-847-22allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED12
56062-847-39allergy relief1 in 1 CARTONTABLET, FILM COATED12
56062-847-39allergy relief30 in 1 BOTTLETABLET, FILM COATED302
56062-847-95allergy relief45 in 1 BOTTLETABLET, FILM COATED452
56062-847-95allergy relief1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-847ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]2Current NDC, Legacy NDC, 6 package rows20220201_76014f1e-fa48-4d64-9ce6-1eaebd0419fc.zip

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
56062-84756062-847-22, 56062-847-39, 56062-847-95

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212971-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24
A212971-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2484e616aacf4f…
2026-09-14 22:38:342026-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2484e616aacf4f…
2026-08-18 06:07:402026-07A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24caaa826d4ba7…
2026-08-18 06:07:402026-07A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212971-001FEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2020-02-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212971-002FEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2020-02-24bb7c543d1eb4…

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
allergy reliefFEXOFENADINE HYDROCHLORIDEPublix Super Markets Inc76014f1e-fa48-4d64-9ce6-1eaebd0419fc2022-01-21WarningsExact identifier
ndc (package): 56062-847-95
ndc (package): 56062-847-22
ndc (package): 56062-847-39
ndc (product): 56062-847
ndc11 (package): 56062084722
ndc11 (package): 56062084739
ndc11 (package): 56062084795
spl id: bdd76b8f-ab6c-477a-81d1-74256944dd62
spl set id: 76014f1e-fa48-4d64-9ce6-1eaebd0419fc

Reported adverse events (FAERS/openFDA)#

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