Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2025-04-18
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:36

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Fexofenadine Hydrochloride USP 180 mg
Pseudoephedrine Hydrochloride USP 240 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 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

Other information

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, dibutyl sebacate, ferrosoferric oxide, glyceryl mono- and di-caprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide

Questions or Comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Manufactured for:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-844-60

*Compare to the active ingredients
in Allegra-D® 24 Hour
Allergy & Congestion Tablets

 Non-Drowsy


Allergy & Congestion

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets USP 180 mg/240 mg

Fexofenadine Hydrochloride 180 mg/antihistamine
Pseudoephedrine Hydrochloride 240 mg/nasal decongestion

24 HR

Indoor / Outdoor Relief Of

  • Nasal and Sinus Congestion Due to Colds or Allergens
  • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies    

Actual size
5 Extended-Release Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997415fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral TabletPSN1
99741524 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral TabletSCD1
997415fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral TabletSY1

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
58602-844-60Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE11
58602-844-60Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE51
58602-844-66Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE21
58602-844-66Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE51
58602-844-85Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride3 in 1 CARTONTABLET, FILM COATED, EXTENDED RE31
58602-844-85Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-844FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROHEALTH LLC]1Current NDC, 6 package rows20250425_bced0a2e-047e-456e-bbd2-495e83bf07ee.zip

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
58602-84458602-844-60, 58602-844-66, 58602-844-85

Ingredients#

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

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

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
A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-1784e616aacf4f…
2026-08-18 06:07:402026-07A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215232-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2025-04-17a50c72e98297…

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 HYDROCHLORIDEAurohealth LLCbced0a2e-047e-456e-bbd2-495e83bf07ee2025-04-18WarningsExact identifier
ndc (package): 58602-844-85
ndc (package): 58602-844-66
ndc (package): 58602-844-60
ndc (product): 58602-844
ndc11 (package): 58602084460
ndc11 (package): 58602084485
ndc11 (package): 58602084466
spl id: bced0a2e-047e-456e-bbd2-495e83bf07ee
spl set id: bced0a2e-047e-456e-bbd2-495e83bf07ee

Reported adverse events (FAERS/openFDA)#

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