Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

Manufacturer: NuCare Pharmaceuticals, Inc.
Effective date: 2017-03-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:17:19

Label at a glance#

Productfexofenadine hydrochloride

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure9 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

do not use if printed foil under cap is broken or missing store at 20°-25°C (68°-77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 3

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

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
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

do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2176-3	2020-04-15	C162847	48780-1	9d75b9d1-0522-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts
68071-2176-9	2020-04-15	C162847	48780-1	9d75b9d1-0522-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts
68071-2176-3	2020-01-31	C162847	48780-1	9d75b9d1-0522-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts
68071-2176-9	2020-01-31	C162847	48780-1	9d75b9d1-0522-f424-e053-dadaa90a57ce	Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-571-78	EA - Each	45802-571	834cc3e1-09bf-4d4e-83ef-1022b7a7595b	1	2012-07-24

Products#

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

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

fexofenadine hydrochloride
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONES
TITANIUM DIOXIDE
FERRIC OXIDE RED
FEXOFENADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-2176	68071-2176-3, 68071-2176-9
45802-571

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
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POVIDONES	FZ989GH94E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	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 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076447-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-09-01
A076447-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2005-09-01
A076447-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2005-09-01
A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-13
A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-13
A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-13

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 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2005-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2005-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-13	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076447-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076447-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076447-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076447-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076447-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076447-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076447-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076447-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076447-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076447-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076447-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076447-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076447-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076447-001	AB	1	`8072bd15b7f6…`

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
a35737f2-dae7-344a-e053-2995a90aee4c			4bce3e4d-c04f-613e-e054-00144ff8d46c	2020-04-15	Warnings	Exact identifier spl set id: 4bce3e4d-c04f-613e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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