Fexofenadine Hydrochloride Tablets, USP 180 mg

Manufacturer: OHM LABORATORIES INC. | Sun Pharmaceutical Industries Limited
Effective date: 2026-05-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:56:00

Label at a glance#

ProductFEXOFENADINE HYDROCHLORIDE

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure11 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

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing store between 20° to 25°C (68° to 77°F) protect from excessive moisture

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-818-4555

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if 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)

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 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

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51660-998-30

ohm Laboratories Inc. (a SUN PHARMA company)

Compare To the active ingredient of

Allegra ^® Allergy

NON-DROWSY

Fexofenadine Hydrochloride
Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour
Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
"SEALED for YOUR PROTECTION" IS TORN OR MISSING

Fexo 180 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	2
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	2
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	2

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	SPL version
51660-998-30	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	2
51660-998-30	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
51660-998-55	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	2
51660-998-55	FEXOFENADINE HYDROCHLORIDE	150 in 1 BOTTLE	TABLET, FILM COATED	150	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51660-998-30	EA - Each	51660-998	148fc51a-2846-4d3f-86d5-0c73ea324946	1	2022-07-06
51660-998-55	EA - Each	51660-998	11233a29-7bc3-43ae-bb1e-0fa9185bc1df	1	2025-08-11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

FEXOFENADINE HYDROCHLORIDE
CROSCARMELLOSE SODIUM
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FEXOFENADINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51660-998	51660-998-30, 51660-998-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
FERRIC OXIDE RED	1K09F3G675	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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-06
A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-06
A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06
A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-06

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 7 · 264 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	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`

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 HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	OHM LABORATORIES INC.	1a1afa95-570d-456e-b436-a0fcfaf68517	2026-05-05	Warnings	Exact identifier ndc (package): 51660-998-30 ndc (package): 51660-998-55 ndc (product): 51660-998 ndc11 (package): 51660099830 ndc11 (package): 51660099855 spl id: 5110b287-1464-50d9-e063-6394a90abe0f spl set id: 1a1afa95-570d-456e-b436-a0fcfaf68517

Reported adverse events (FAERS/openFDA)#

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