FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Cardinal Health

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 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 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

Inactive ingredients

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

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

DISTRIBUTED BY
CARDINAL HEALTH,
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2x10 Blister Carton

LEADER

NDC 70000-0677-1

NON-DROWSY

12HR Allergy & Congestion Relief

Fexofenadine HCl 60 mg | Pseudoephedrine HCl 120 mg
Extended-Release Tablets, USP
Antihistamine | Nasal Decongestion

Indoor / Outdoor Relief Of:

•    Nasal and Sinus Congestion

       Due to Colds or Allergies

•    Sneezing; Runny Nose; Itchy, Watery Eyes
       and Itchy Nose or Throat Due to Allergies    


Actual Size

COMPARE TO
ALLEGRA-D®
12 HOUR ALLERGY
& CONGESTION TABLETS
active ingredients*

20 EXTENDED-RELEASE
     TABLETS
fexofenadine-fig1

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0677
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOW (White to Off White Layer and Yellow to Pale Yellow) Scoreno score
ShapeCAPSULE (Bincovex) Size19mm
FlavorImprint Code Z;79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0677-12 in 1 CARTON05/15/2024
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70000-0677-23 in 1 CARTON05/15/2024
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20911605/15/2024
Labeler - Cardinal Health (063997360)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(70000-0677) , MANUFACTURE(70000-0677)

Revised: 5/2024
Document Id: c3b40d04-7eef-4c80-a604-808d2be72ad7
Set id: c3b40d04-7eef-4c80-a604-808d2be72ad7
Version: 1
Effective Time: 20240506
 
Cardinal Health