Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP

Manufacturer: Walgreens Company
Effective date: 2015-08-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:00:25

Label at a glance#

ProductFexofenadine HCl and Pseudoephedrine HCI

Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure11 sections

Dosage and administration

do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; 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

Storage and handling

store between 20° to 25°C (68° to 77°F)

Contacts and useful links#

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
nasal congestion
itchy, watery eyes
itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
thyroid disease
glaucoma
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
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)
the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions).

Stop use and ask doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve within 7 days or are accompanied by a fever
you get nervous, dizzy, or sleepless

Pregnancy/Breastfeeding

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 contacta Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years of age and over	take 1 tablet with a glass of water every 12 hours on an empty stomach; 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

Other information

SPL UNCLASSIFIED SECTION

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
this product meets the requirements of USP dissolution test 3.

Storage

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

placeholder

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997406	fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	2
997406	12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	2
997406	fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-1606-20	Fexofenadine HCl and Pseudoephedrine HCI	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5	2
0363-1606-20	Fexofenadine HCl and Pseudoephedrine HCI	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	2
0363-1606-30	Fexofenadine HCl and Pseudoephedrine HCI	6 in 1 CARTON	TABLET, EXTENDED RELEASE	6	2
0363-1606-30	Fexofenadine HCl and Pseudoephedrine HCI	5 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	5	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1606	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [WALGREENS COMPANY]	2	Current NDC, Legacy NDC, 4 package rows	20190916_37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

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

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

Fexofenadine HCl and Pseudoephedrine HCI
FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE
MANNITOL
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
POWDERED CELLULOSE
STARCH, CORN
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
HYPROMELLOSES
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-1606	0363-1606-30, 0363-1606-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
MANNITOL	3OWL53L36A	IACT
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
POWDERED CELLULOSE	SMD1X3XO9M	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
TRIETHYL CITRATE	8Z96QXD6UM	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 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL	7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, EXTENDED RELEASE / ORAL	156 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL	450 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL	1086 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL	450 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL	160 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL	450 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL	1086 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL	173 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL	184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, EXTENDED RELEASE / ORAL	156 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL	160 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL	184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL	392 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL	7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL	184 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL	1472 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, EXTENDED RELEASE / ORAL	1086 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL	7 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, EXTENDED RELEASE / ORAL	156 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL	160 mg	Exact identifier — unii+route+dosage form 3 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2014-11-18

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 2 · 43 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	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076667-001	FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	60MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2014-11-18	`f41ea6bd6efb…`

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 and Pseudoephedrine HCI	FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI	Walgreens Company	37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3	2015-08-04	Warnings	Exact identifier ndc (package): 0363-1606-30 ndc (package): 0363-1606-20 ndc (product): 0363-1606 ndc11 (package): 00363160620 ndc11 (package): 00363160630 spl id: 22a37aee-5811-616b-a794-4c24bd940d73 spl set id: 37c1ce51-fb5d-7ebf-bbcd-1b2fd41d45b3

Reported adverse events (FAERS/openFDA)#

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