FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 
PUBLIX SUPER MARKETS, INC

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each extended-release tablet)

Fexofenadine HCl, USP 60 mg

Pseudoephedrine HCl, USP 120 mg

Purpose

Antihistamine

Nasal 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.

In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222)

Keep Out of Reach of Children.

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, magnesuim stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

NDC 41415-995-20

12-HOUR • NON-DROWSY

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY & CONGESTION

12-hour relief of:
• Nasal and sinus congestion due to colds or allergies
• Sneezing • Runny nose • Itchy, watery eyes
• Itchy throat or nose due to allergies

INDOOR AND OUTDOOR ALLERGIES

20
EXTENDED-RELEASE
TABLETS

ACTUAL SIZE

Do not use if individual blister unit is open or torn.

*Compare to the active
ingredients of Allegra-D®

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

NDC 41415-995-30

12-HOUR • NON-DROWSY

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY & CONGESTION

12-hour relief of:
• Nasal and sinus congestion due to colds or allergies
• Sneezing • Runny nose • Itchy, watery eyes
• Itchy throat or nose due to allergies

INDOOR AND OUTDOOR ALLERGIES

30
EXTENDED-RELEASE
TABLETS

Do not use if individual blister unit is open or torn.

*Compare to the active
ingredients of Allegra-D®

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-995
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, UNSPECIFIED (UNII: FZ989GH94E)  
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
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code 724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41415-995-201 in 1 CARTON11/08/2021
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41415-995-301 in 1 CARTON11/08/2021
230 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081811/08/2021
Labeler - PUBLIX SUPER MARKETS, INC (006922009)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(41415-995) , MANUFACTURE(41415-995)

Revised: 4/2022
Document Id: 9da8a36f-ad09-41c5-a47f-e82ba723d828
Set id: 75236b23-af51-40b6-ad1b-f62a27093a16
Version: 2
Effective Time: 20220404
 
PUBLIX SUPER MARKETS, INC