Fexofenadine Hydrochloride Tablets, USP

Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date: 2018-10-26
Label type: Human OTC Drug Label
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:57:05

Label at a glance#

ProductFEXOFENADINE HYDROCHLORIDE

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure17 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

For 30mg: adults and children 12 years of age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor For 60mg:...

Contacts and useful links#

PhoneLabel contact1-800-818-4555

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

For 30 mg:
Fexofenadine HCl, USP 30 mg

For 60 mg:
Fexofenadine HCl, USP 60 mg

For 180 mg:
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
sneezing
itchy, watery eyes
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

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 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

For 30mg:

adults and children 12 years of age and over	take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

For 60mg:

adults and children 12 years of age and over	take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

For 180mg:

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

SPL UNCLASSIFIED SECTION

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 30 mg Allergy:

ORIGINAL PRESCRIPTION STRENGTH
NDC 62756-542-88
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 30 mg each
SUN PHARMA

30mg-allergy-2
30mg-allergy-3
30mg-allergy-4
30mg-allergy-5
30mg-allergy-6
30mg-allergy-7
For 60 mg Allergy:

NDC 62756-543-88
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 60 mg each
SUN PHARMA

60mg-allergy-3
For 180 mg Allergy:

NDC 62756-545-88
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 180 mg each
SUN PHARMA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 30 mg Allergy:

NDC 62756-542-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Ages 6 years and Older
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 30 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
30mg-allergy-sb

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 60 mg Allergy:

NDC 62756-543-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 60 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
60mg-allergy-sb

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 180 mg Allergy:

NDC 62756-545-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 180 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	6
997488	fexofenadine HCl 30 MG Oral Tablet	PSN	6
997501	fexofenadine HCl 60 MG Oral Tablet	PSN	6
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	6
997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD	6
997501	fexofenadine hydrochloride 60 MG Oral Tablet	SCD	6
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62756-542-64	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-66	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-74	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-76	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-77	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-78	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-83	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-542-88	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-64	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-66	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-74	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-76	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-77	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-78	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-83	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-543-88	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-64	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-66	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-74	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-76	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-77	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-78	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-83	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP
62756-545-88	2023-01-30	C162847	48780-1	f386c64a-0d6d-0266-e053-dadaa90a7c1a	Fexofenadine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-542-64	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-542-64	FEXOFENADINE HYDROCHLORIDE	5 in 1 CARTON	TABLET, FILM COATED	5	6
62756-542-66	FEXOFENADINE HYDROCHLORIDE	2 in 1 CARTON	TABLET, FILM COATED	2	6
62756-542-66	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-542-74	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	6
62756-542-74	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-542-76	FEXOFENADINE HYDROCHLORIDE	10 in 1 CARTON	TABLET, FILM COATED	10	6
62756-542-76	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-542-77	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-542-77	FEXOFENADINE HYDROCHLORIDE	9 in 1 CARTON	TABLET, FILM COATED	9	6
62756-542-78	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-542-78	FEXOFENADINE HYDROCHLORIDE	15 in 1 CARTON	TABLET, FILM COATED	15	6
62756-542-83	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
62756-542-88	FEXOFENADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
62756-543-64	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-64	FEXOFENADINE HYDROCHLORIDE	5 in 1 CARTON	TABLET, FILM COATED	5	6
62756-543-66	FEXOFENADINE HYDROCHLORIDE	2 in 1 CARTON	TABLET, FILM COATED	2	6
62756-543-66	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-74	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	6
62756-543-74	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-76	FEXOFENADINE HYDROCHLORIDE	10 in 1 CARTON	TABLET, FILM COATED	10	6
62756-543-76	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-77	FEXOFENADINE HYDROCHLORIDE	9 in 1 CARTON	TABLET, FILM COATED	9	6
62756-543-77	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-543-78	FEXOFENADINE HYDROCHLORIDE	15 in 1 CARTON	TABLET, FILM COATED	15	6
62756-543-78	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-543-83	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
62756-543-88	FEXOFENADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
62756-545-64	FEXOFENADINE HYDROCHLORIDE	5 in 1 CARTON	TABLET, FILM COATED	5	6
62756-545-64	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-545-66	FEXOFENADINE HYDROCHLORIDE	2 in 1 CARTON	TABLET, FILM COATED	2	6
62756-545-66	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-545-74	FEXOFENADINE HYDROCHLORIDE	1 in 1 CARTON	TABLET, FILM COATED	1	6
62756-545-74	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-545-76	FEXOFENADINE HYDROCHLORIDE	10 in 1 CARTON	TABLET, FILM COATED	10	6
62756-545-76	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-545-77	FEXOFENADINE HYDROCHLORIDE	9 in 1 CARTON	TABLET, FILM COATED	9	6
62756-545-77	FEXOFENADINE HYDROCHLORIDE	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	6
62756-545-78	FEXOFENADINE HYDROCHLORIDE	15 in 1 CARTON	TABLET, FILM COATED	15	6
62756-545-78	FEXOFENADINE HYDROCHLORIDE	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	6
62756-545-83	FEXOFENADINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
62756-545-88	FEXOFENADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-542	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 14 package rows	20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip
62756-543	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 14 package rows	20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip
62756-545	FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Legacy NDC, 14 package rows	20181026_04923af6-97fc-4e32-834d-1df643832d7f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62756-542	62756-542-83, 62756-542-88, 62756-542-74, 62756-542-66, 62756-542-77, 62756-542-64, 62756-542-76, 62756-542-78
62756-543	62756-543-83, 62756-543-88, 62756-543-74, 62756-543-66, 62756-543-77, 62756-543-64, 62756-543-76, 62756-543-78
62756-545	62756-545-83, 62756-545-88, 62756-545-74, 62756-545-66, 62756-545-77, 62756-545-64, 62756-545-76, 62756-545-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSPOVIDONE	68401960MK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSPOVIDONE	68401960MK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSPOVIDONE	68401960MK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 222 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL		8 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates

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 · 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 · 258 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091567-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091567-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-06	`b8a1b40f171c…`

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
e7c52e0c-a809-4d57-9cb6-570029c2a85f			04923af6-97fc-4e32-834d-1df643832d7f	2018-10-26	Warnings	Exact identifier spl id: e7c52e0c-a809-4d57-9cb6-570029c2a85f spl set id: 04923af6-97fc-4e32-834d-1df643832d7f

Reported adverse events (FAERS/openFDA)#

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