Fexofenadine HCl

Manufacturer: Advanced Rx LLC
Effective date: 2024-09-10
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:19:22

Label at a glance#

ProductFexofenadine HCl

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure10 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

Storage and handling

store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 8.2 mg this product meets the requirements of USP Dissolution Test 2 DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-630-8895

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
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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

STORAGE AND HANDLING SECTION

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains:sodium 8.2 mg
this product meets the requirements of USP Dissolution Test 2
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions?

OTC - QUESTIONS SECTION

call toll free 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-506-01

Compare to the active ingredient in Allegra ^®Allergy 24 Hour Tablets ^*

Non-Drowsy

Allergy Relief

Fexofenadine HCL 180 mg

INDOOR & OUTDOOR ALLERGY

24-Hour Allergy Relief Of:

Sneezing, runny nose
Itchy, watery eyes
Itchy throat or nose

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Allegra ^®Allergy 24 Hour Tablets.

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	1
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	1
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80513-506-01	Fexofenadine HCl	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80513-506	FEXOFENADINE HCL TABLET, FILM COATED [ADVANCED RX LLC]	1	Current NDC, 1 package rows	20240912_c067b335-79c5-4176-a0b3-bae02a0c23f8.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Fexofenadine HCl
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
STEARIC ACID
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80513-506	80513-506-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STEARIC ACID	4ELV7Z65AP	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2015-09-16
A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2015-09-16
A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2015-09-16
A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2015-09-16

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-003	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-004	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204507-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2015-09-16	`2680178bc6a6…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fexofenadine HCl	FEXOFENADINE HCL	Advanced Rx LLC	c067b335-79c5-4176-a0b3-bae02a0c23f8	2024-09-10	Warnings	Exact identifier ndc (package): 80513-506-01 ndc (product): 80513-506 ndc11 (package): 80513050601 spl id: 21be7a92-2648-b2bf-e063-6394a90ac580 spl set id: c067b335-79c5-4176-a0b3-bae02a0c23f8

Reported adverse events (FAERS/openFDA)#

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