FDA.reportPublic FDA data

Allergy Relief

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:05

Label at a glance#

Product24HR Allergy Relief
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

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

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine Hydrochloride 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.

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 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

SPL UNCLASSIFIED SECTION

  • Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80,
pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 LABEL180 LABEL

180 CARTON180 CARTON

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
70000-0726-124HR Allergy Relief180 in 1 BOTTLETABLET1802
70000-0726-124HR Allergy Relief1 in 1 CARTONTABLET12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-072670000-0726-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PARAFFINI9O0E3H2ZEIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TALC7SEV7J4R1UIACT
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2016-08-19
A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2016-08-19
A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2016-08-19

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 22:38:342026-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-09-14 22:38:342026-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19301d65b070ca…

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
24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERb72c4802-1bcb-48bc-b4b9-72167ea4643e2025-06-12WarningsExact identifier
ndc (package): 70000-0726-1
ndc (product): 70000-0726
ndc11 (package): 70000072601
spl id: f41aacbe-2d4d-484a-8f88-a8ca080d6c8a
spl set id: b72c4802-1bcb-48bc-b4b9-72167ea4643e

Reported adverse events (FAERS/openFDA)#

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