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

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

Active ingredients

(in each extended-release tablet)
Fexofenadine HCl, USP 60 mg
Pseudoephedrine HCl, USP 120 mg

Purpose

Antihistamine
Nasal Decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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 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.

Directions


do not divide, crush, chew or dissolve the tablet; swallow tablet whole

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

do not use if carton is opened or if individual blister units are torn or opened.
store between 20° to 25°C (68° to 77°F)
USP dissolution test is pending.

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

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

NON-DROWSY
ORIGINAL PRESCRIPTION STRENGTH

Walgreens

Wal-Fex® D

ALLERGY & CONGESTION

FEXOFENADINE HCl 60 mg / ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg / NASAL DECONGESTANT

12 HOUR
EXTENDED-RELEASE TABLETS, USP

INDOOR & OUTDOOR ALLERGIES

30
EXTENDED-RELEASE
TABLETS

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Compare to Allegra-D® 12 Hour Allergy &
Congestion Tablets active ingredients††

NDC 0363-2110-30

12
HOUR

ACTUAL SIZE

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:0363-2110
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:0363-2110-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product04/17/2018
2NDC:0363-2110-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product04/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081804/17/2018
Labeler - walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(0363-2110) , MANUFACTURE(0363-2110)

Revised: 2/2019
Document Id: acf43ee3-0615-44af-9d2a-54052c9b3af1
Set id: 1ed05c85-7a1c-440d-a5d7-e229528cedcd
Version: 3
Effective Time: 20190213
 
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