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

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60 mg/120 mg

Active ingredient(s)


(in each extended-release 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 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 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, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Questions?


Call toll free 1-800-818-4555 weekdays

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton

CVSHealth

Compare to the active ingredients in Allegra-D®*

Indoor & Outdoor Allergies

Original Prescription Strength
ALLERGY & CONGESTION RELIEF

Allergy Relief D

FEXOFENADINE HCl 60 mg/Antihistamine
PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant
EXTENDED RELEASE TABLETS, USP

12
HOUR

12 Hour Relief of:

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Non-Drowsy

20 EXTENDED-RELEASE TABLETS

Actual Size

Principal Display Panel -  60 mg/120 mg Tablet Blister Pack 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:69842-990
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorWHITE, YELLOWScoreno score
ShapeOVAL (bilayer) Size17mm
FlavorImprint Code 724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-990-201 in 1 CARTON03/01/2018
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-990-301 in 1 CARTON03/01/2018
230 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081803/01/2018
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(69842-990) , MANUFACTURE(69842-990)

Revised: 5/2018
Document Id: f6c3f3ab-f5b1-40d1-8ca9-51f55b9c66a9
Set id: 02476e5a-0463-4223-8dc5-8bbe787d38dc
Version: 1
Effective Time: 20180531
 
CVS Pharmacy