FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Sun Pharmaceutical Industries, Inc.

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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 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 age do 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?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

NDC 47335-724-83

ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP

60 mg/120 mg
ALLERGY &
CONGESTION
12 HR
Antihistamine/Nasal Decongestant
Indoor and Outdoor Allergies
30 Tablets
SUN PHARMA

spl-fexofenadine-label1

Principal Display Panel-Showbox

NDC 47335-724-94
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY

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

ALLERGY & CONGESTION

12 HR

Antihistamine/Nasal Decongestant

10 Extended-Release Tablets

INDOOR / OUTDOOR RELIEF OF
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
SUN PHARMA
SPL-fexofenadine-showbox

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-724
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (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:47335-724-8330 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
2NDC:47335-724-941 in 1 CARTON03/01/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:47335-724-992 in 1 CARTON03/01/2018
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:47335-724-953 in 1 CARTON03/01/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:47335-724-662 in 1 CARTON03/01/2018
55 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:47335-724-754 in 1 CARTON03/01/2018
65 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:47335-724-646 in 1 CARTON03/01/2018
75 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 - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(47335-724) , MANUFACTURE(47335-724)

Revised: 9/2023
Document Id: 500a47c2-26a8-4dce-9e99-a7c9b69e84c1
Set id: 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1
Version: 12
Effective Time: 20230926
 
Sun Pharmaceutical Industries, Inc.