FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
AmeriSource Bergen

----------

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 AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087

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

GOOD
NEIGHBOR
PHARMACY®

Compare to Allegra-D® active ingredients**

NDC 46122-452-60

Original Prescription Strength

NON-DROWSY

12 HOUR

fexofenadine HCl 60 mg/antihistamine
pseudoephedrine HCl 120 mg/nasal decongestant
Extended-Release Tablets, USP

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

20 Extended-Release Tablets

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:46122-452
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
ShapeCAPSULE (bilayer) Size17mm
FlavorImprint Code 724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-452-601 in 1 CARTON03/01/2018
120 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 - AmeriSource Bergen (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(46122-452) , MANUFACTURE(46122-452)

Revised: 5/2018
Document Id: e29de5ab-e8fe-4d85-99fa-f867dd10273c
Set id: c20f780c-562b-4eb6-940d-2973382118eb
Version: 1
Effective Time: 20180531
 
AmeriSource Bergen