FDA.reportPublic FDA data

Fexofenadine Hydrochloride Tablets USP, 180 mg

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-10-20 03:02:48

Label at a glance#

ProductFexofenadine HCL
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 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

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

        • Tamper-Evident: Do not use if seal is missing from bottle.
• 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 1-800-206-7821

HOW SUPPLIED

HOW SUPPLIED SECTION

Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows:

NDC 72789-196-10 in bottles of 10 tablets

NDC 72789-196-30 in bottles of 30 tablets

NDC 72789-196-90 in bottles of 90 tablets

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 180 mg


PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00372789196305(21)I22C43000004(17)240930(10)I22C43GTIN-14: 00372789196305
GTIN-12: 372789196305
UPC-A: 372789196305
EAN-13: 0372789196305
GTIN storage (14 digits): 00372789196305		72789196.jpg
BarcodeEAN-130372789196305GTIN-13: 0372789196305
EAN-13: 0372789196305
GTIN-12: 372789196305
UPC-A: 372789196305
GTIN storage (14 digits): 00372789196305		72789196.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-196-10EA - Each72789-196774388b3-587e-4576-8a98-6c9731aea95b12023-04-07
72789-196-30EA - Each72789-19613969256-4510-4e23-98e5-2998857f042b12022-10-06
72789-196-90EA - Each72789-1966cf5b51e-42b4-4bb5-8d33-b70823cd91f412021-08-05
16714-899-01EA - Each16714-89968d66b2e-0c9c-4244-879c-b950a7997e2c12019-08-06
16714-899-02EA - Each16714-89977401375-1123-4070-ae19-c8a1cebe541112019-08-06

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
72789-19672789-196-90, 72789-196-30, 72789-196-10
16714-899

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
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
LIGHT MINERAL OILN6K5787QVPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
FERRIC OXIDE RED1K09F3G675IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-10-08full-release2026-06-01 01:38:15
82024-10-09full-release2026-06-01 00:23:51

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 45.

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 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d4dbc9d85df4…
2026-11-14 07:37:172026-10A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d4dbc9d85df4…
2026-11-14 07:37:172026-10A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d4dbc9d85df4…
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…

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
40ac042c-0bf7-c7f4-e063-6294a90a409407460764-43fa-49fd-ae77-d4571cb9f9442025-10-08WarningsExact identifier
spl set id: 07460764-43fa-49fd-ae77-d4571cb9f944
Fexofenadine HCLFEXOFENADINE HCLNorthStar RxLLC9c308a91-640d-441b-8fb5-acb5a415405e2019-04-30WarningsExact identifier
ndc (product): 16714-899

Reported adverse events (FAERS/openFDA)#

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