FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
KROGER COMPANY

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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?
1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI,
OHIO 45202


MADE IN INDIA

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 x 10 Blister Carton

COMPARE TO the active ingredients of ALLEGRA-D® 12 HOUR
ALLERGY & CONGESTION TABLETS
*See bottom panel                            NDC 30142-059-84
Kroger®
Non-Drowsy
Allergy & Congestion

Fexofenadine HCl and
Pseudoephedrine HCl
Extended-Release
Tablets USP 60 mg / 120 mg

Fexofenadine HCl
60 mg / Antihistamine
Pseudoephedrine HCl
120 mg / Nasal Decongestant

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    

actual size
79


30 EXTENDED
RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 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:30142-059
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:30142-059-843 in 1 CARTON03/15/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20911603/15/2021
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(30142-059) , MANUFACTURE(30142-059)

Revised: 8/2022
Document Id: ace3970d-b14d-43df-99da-88343d9dc152
Set id: b8b2c45d-3aba-d98a-e053-2a95a90a879b
Version: 3
Effective Time: 20220804
 
KROGER COMPANY