Fexofenadine Hydrochloride Tablets USP, 180 mg

Manufacturer
Walmart Inc | Hetero Labs Limited Unit V
Effective date
2026-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-11-03 06:09:23

Label at a glance#

ProductEquate
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure13 sections

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#

ACTIVE INGREDIENT(S) in each tablet

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine hydrochloride USP, 180 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

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


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

OTC - ASK DOCTOR SECTION

you have 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

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

If pregnant or breast-feeding,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 overtake 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

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?

SPL UNCLASSIFIED SECTION

Call 1-888-287-1915


DISTRIBUTED BY: Walmart Inc.,

Bentonville,AR72716

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Fexofenadine Hydrochloride Tablets USP, 180 mg - 45s container label

fexofenadine180mg45label
fexofenadine180mg45label
fexofenadine180mg452label
fexofenadine180mg452label

 
Fexofenadine Hydrochloride Tablets USP, 180 mg - 45s container carton


fexofenadine180mg45carton
fexofenadine180mg45carton

Fexofenadine Hydrochloride Tablets USP, 180 mg - 90s container carton


fexofenadine180mg90carton
fexofenadine180mg90carton


Fexofenadine Hydrochloride Tablets USP, 180 mg - 90s container label

fexofenadine180mg90label
fexofenadine180mg90label
fexofenadine180mg902label
fexofenadine180mg902label

Fexofenadine Hydrochloride Tablets USP, 180 mg - 300s container label


fexofenadine180mg300label
fexofenadine180mg300label

fexofenadine180mg3002label
fexofenadine180mg3002label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130194346693276GTIN-13: 0194346693276
EAN-13: 0194346693276
GTIN-12: 194346693276
UPC-A: 194346693276
GTIN storage (14 digits): 00194346693276
fexofenadine180mg90carton.jpg
BarcodeEAN-130194346693283GTIN-13: 0194346693283
EAN-13: 0194346693283
GTIN-12: 194346693283
UPC-A: 194346693283
GTIN storage (14 digits): 00194346693283
fexofenadine180mg300label.jpg
Data codeData MatrixWMO-CTN-044fexofenadine180mg45carton.jpg
Data codeData MatrixWMO-LBL-063fexofenadine180mg45label.jpg
Data codeData MatrixWMO-LBL-064fexofenadine180mg90label.jpg
Data codeData MatrixWMO-LBL-065fexofenadine180mg300label.jpg

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-44179903-441-45, 79903-441-90, 79903-441-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19c2088c7a36db…
2026-10-15 13:18:302026-09A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19c2088c7a36db…
2026-10-15 13:18:302026-09A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19c2088c7a36db…
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…

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 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VALUMEDS NON-DROWSY ALLERGY RELIEF FEXOFENADINE HCLFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.f9ccd673-c65f-45c6-9863-26136eb816db2026-10-08WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGYFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC1b5aa481-205d-4935-ae58-fcb8cbc35c4c2026-09-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed3796ee-3078-e850-e053-2a95a90a318a2026-09-03WarningsName fallback
brand name: Equate
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed63bd55-941f-9785-e053-2995a90a59522026-09-03WarningsName fallback
brand name: Equate
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEBi-Mart0a3d4d1f-a99f-4d0a-bb28-b2409a9e073a2026-08-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.b21bb11d-bf74-4ee7-9cfe-5b599a3c47752026-08-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC5413d84e-f945-4920-8981-f62978f21d672026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC683cb2ea-c913-48f4-8adc-2888da3b655e2026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLCeb8e67dc-e2df-4c35-bfd7-12af67e1354a2026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072026-08-05WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-08-03WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
equate allergy reliefFEXOFENADINE HYDROCHLORIDEWalmart Inc.852c8ad2-fc7d-4728-b2c6-f64b960fe2ab2026-07-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens AllergyFEXOFENADINE HYDROCHLORIDEH2-Pharma, LLC84988f6d-85b1-45dd-89be-0333acc6b1802026-06-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs58193632-2468-4159-b1a9-c24a489f199f2026-06-24WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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