FDA.reportPublic FDA data

Fexofenadine HCl 180 mg and Pseudoephedrine HCI 240 mg ER Tablets, USP

Manufacturer
Walmart Inc.
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:19

Label at a glance#

ProductFexofenadine HCl and Pseudoephedrine HCl
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 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 24 hours on an empty stomach; 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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 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
  • 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

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 take as 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

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

  • 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 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: 28 mg sodium
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° - 25°C (68° - 77°F)
  • FDA approved dissolution test specifications differ from USP

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

Questions?

OTC - QUESTIONS SECTION

Questions?Call 1-888-287-1915 Weekdays (8am - 8pm EST)

Distributed by:

Walmart Inc.,

Bentonville, AR 72716

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN4
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD4
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY4

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
79903-255-05Fexofenadine HCl and Pseudoephedrine HCl5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE54
79903-255-10Fexofenadine HCl and Pseudoephedrine HCl2 in 1 CARTONTABLET, EXTENDED RELEASE24

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-25579903-255-05, 79903-255-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
ACETONE1364PS73AFIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE ACETATE3J2P07GVB6IACT
COPOVIDONED9C330MD8BIACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
ISOPROPYL ALCOHOLND2M416302IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
FERRIC OXIDE RED1K09F3G675IACT
POVIDONE K30U725QWY32XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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
83a5d9eb-bd3e-cc54-e27d-0271a3391d2c883d21cd-4c5f-b502-1465-e346ecc2e2ec2025-07-22WarningsExact identifier
spl id: 83a5d9eb-bd3e-cc54-e27d-0271a3391d2c
spl set id: 883d21cd-4c5f-b502-1465-e346ecc2e2ec

Reported adverse events (FAERS/openFDA)#

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