Allergy Relief

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Effective date
2025-03-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:40:53

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 

Storage and handling

safety sealed: do not use if printed safety seal under cap is missing or broken or if individual blister units are torn or opened store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture

Label contents#

Full prescribing information#

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 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

  • safety sealed: do not use if printed safety seal under cap is missing or broken or if individual blister units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Allegra® Allergy 24 Hour active ingredient*

NON-DROWSY

Allergy Relief

Fexofenadine HCL USP 180 mg tablets

Antihistamine

24-hour relief of

  • Sneezing
  • Runny Nose
  • Itchy, watery eyes
  • Itchy nose or throat

Indoor and outdoor allergy relief

CAPLETS

(**Capsule-Shaped tablets

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

TAMPER EVIDENTDP NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUATE Non-Drowsy Allergy Relief
EQUATE Non-Drowsy Allergy Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-504ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]7Legacy NDC20250305_b8cd43d2-9cfa-47e2-a3c6-1a31a5d6fcf4.zip

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
49035-50449035-504-12, 49035-504-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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
2391e28c-500e-48e0-9b09-5742edcf3d8db8cd43d2-9cfa-47e2-a3c6-1a31a5d6fcf42025-03-03WarningsExact identifier
spl id: 2391e28c-500e-48e0-9b09-5742edcf3d8d
spl set id: b8cd43d2-9cfa-47e2-a3c6-1a31a5d6fcf4

Reported adverse events (FAERS/openFDA)#

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