FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Aurohealth LLC

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP

Drug Facts

Active ingredients (in each tablet)

Fexofenadine Hydrochloride USP 180 mg
Pseudoephedrine Hydrochloride USP 240 mg

Purpose

Antihistamine
Nasal decongestant

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions


 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

Inactive ingredients

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

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

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

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-844
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE240 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE 200 (UNII: 5XDI2TS1EZ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (biconvex with slightly blister surfaced) Size13mm
FlavorImprint Code FES
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-844-601 in 1 CARTON04/17/2025
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-844-662 in 1 CARTON04/17/2025
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-844-853 in 1 CARTON04/17/2025
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21523204/17/2025
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-844) , MANUFACTURE(58602-844)

Revised: 4/2025
Document Id: bced0a2e-047e-456e-bbd2-495e83bf07ee
Set id: bced0a2e-047e-456e-bbd2-495e83bf07ee
Version: 1
Effective Time: 20250418
 
Aurohealth LLC