FDA.reportPublic FDA data

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Manufacturer
CVS Pharmacy, Inc. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-06-01
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:23

Label at a glance#

ProductFexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

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 Other information safety sealed: do not use i...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

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
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

  • 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 take as directed (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.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • you get nervous, dizzy, or sleepless

If pregnant or breast-feeding, 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 (1-800-222-1222) 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

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened. 
  • store at 20-25°C (68-77°F).
  • Meets USP dissolution test 7

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com®  1-800-SHOP CVS

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth®

Compare to the active ingredients in Allegra-D®
12 Hour Allergy & Congestion Tablets*

NDC 51316-007-67

Non-Drowsy
ALLERGY & CONGESTION RELIRF
Allergy Relief D
Fexofenadine HCl  60 mg/Antihistamine
PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant
EXTENDED-RELEASE TABLETS, USP
12
HOUR

INDOOR/OUTDOOR RELIEF OF:


•  Nasal & sinus congestion due to
    colds or allergies

•  Sneezing; Runny nose; Itchy, watery eyes 
    & Itchy nose or throat due to allergies    


20 EXTENDED-RELEASE TABLETS                         Actual Size 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 Blister CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 Blister Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-007-67Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE23
51316-007-67Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE103
51316-007-84Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride3 in 1 CARTONTABLET, FILM COATED, EXTENDED RE33
51316-007-84Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-007FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY, INC.]3Current NDC, Legacy NDC, 4 package rows20240628_e9161bb2-190f-14b3-e053-2995a90a9b2f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-00751316-007-67, 51316-007-84

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
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2208 (100000 MPA.S)VM7F0B23ZIIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)5Y0974F5PWIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3084e616aacf4f…
2026-08-18 06:07:402026-07A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209116-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2017-10-30f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.e9161bb2-190f-14b3-e053-2995a90a9b2f2024-06-01WarningsExact identifier
ndc (package): 51316-007-84
ndc (package): 51316-007-67
ndc (product): 51316-007
ndc11 (package): 51316000784
ndc11 (package): 51316000767
spl id: ca6c580e-a29b-4698-a226-bb8e3bdee26b
spl set id: e9161bb2-190f-14b3-e053-2995a90a9b2f

Reported adverse events (FAERS/openFDA)#

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