Fexofenadine HCl

Manufacturer: Rite Aid
Effective date: 2025-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:27:41

Label at a glance#

ProductFexofenadine HCl

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure14 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 take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours years of age and over children under do not use 12 years of age adults 65 years ask a doctor of age and older consumers with ask a doctor kidney disease

Storage and handling

􀂄 safety sealed: do not use if imprinted foil under bottle cap is opened or torn 􀂄 store between 20° and 25°C (68° and 77°F) 􀂄 protect from excessive moisture

Contacts and useful links#

PhoneLabel contact1-877-770-3183

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 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

WARNINGS 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 take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
years of age and over

children under do not use
12 years of age

adults 65 years ask a doctor
of age and older

consumers with ask a doctor
kidney disease

Other information

STORAGE AND HANDLING SECTION

􀂄 safety sealed: do not use if imprinted foil under bottle cap is opened or torn
􀂄 store between 20° and 25°C (68° and 77°F)
􀂄 protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate,
macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexo 180mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	3
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	3
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	3

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
11822-7661-5	Fexofenadine HCl	766 in 1 BOTTLE	TABLET	766		3

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Fexofenadine HCl
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE
POLYETHYLENE GLYCOL 6000
STARCH, CORN
FERROSOFERRIC OXIDE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-7661	11822-7661-5

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (15 MPA.S)	36SFW2JZ0W	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
STARCH, CORN	O8232NY3SJ	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL			2019-10-18
A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL			2019-10-18

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211075-001	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211075-002	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2019-10-18	`74a2ff9319b5…`

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	Rite Aid	1ddae2a1-0e16-e294-e063-6394a90a05f5	2025-12-19	Warnings	Exact identifier ndc (package): 11822-7661-5 ndc (product): 11822-7661 ndc11 (package): 11822766105 spl id: 46553fb2-9547-c6e0-e063-6394a90a2633 spl set id: 1ddae2a1-0e16-e294-e063-6394a90a05f5

Reported adverse events (FAERS/openFDA)#

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