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

----------

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each extended-release tablet)Purpose
Fexofenadine HCl, USP 60 mgAntihistamine
Pseudoephedrine HCl, USP 120 mgNasal Decongestant

Uses

Warnings

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have difficulty swallowing

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • kidney disease. Your doctor should determine if you need a different dose.

When using this product

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • you get nervous, dizzy, or sleepless

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 (1800-222-1222).

Directions

adults and children 12 years of age and overtake 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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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 or comments?

Call toll-free 1-800-818-4555 weekdays

Distributed By:
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

Compare to Allegra-D® active ingredients**

Rx
GOOD
NEIGHBOR
PHARMACY®

NDC 46122-694-65

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:

30 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 30 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:46122-694
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:46122-694-653 in 1 CARTON03/01/2018
110 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(46122-694) , MANUFACTURE(46122-694)

Revised: 4/2021
Document Id: e1aa7e23-30a8-46dd-bfaa-ef3428447c60
Set id: 4a8df3c9-bed3-4371-a1c1-59afe12203e2
Version: 1
Effective Time: 20210428
 
AmeriSource Bergen