FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
CVS Pharmacy, Inc.

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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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com®  1-800-SHOP CVS

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton

CVSHealth®

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

NDC 51316-007-67


Original Prescription Strength
ALLERGY & CONGESTION RELIRF
Allergy Relief D

Fexofenadine HCl  60 mg/ Antihistamine
PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant
EXTENDED-RELEASE TABLETS, USP

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    


Non-drowsy

20 EXTENDED-RELEASE TABLETS                  

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 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:51316-007
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:51316-007-672 in 1 CARTON11/17/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51316-007-843 in 1 CARTON11/17/2022
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20911611/17/2022
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(51316-007) , MANUFACTURE(51316-007)

Revised: 11/2022
Document Id: 46975e97-aa0a-4ae8-88e5-13d6fe3443de
Set id: e9161bb2-190f-14b3-e053-2995a90a9b2f
Version: 2
Effective Time: 20221121
 
CVS Pharmacy, Inc.