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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Medically reviewed on February 16, 2018

Dosage form: tablet, film coated, extended release
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg, PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Sun Pharma Global FZE
NDC Code: 47335-724

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
  • 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
  • safety sealed; do not use if inner safety seal is open or torn
  • 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?

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






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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
POVIDONE K30 
MAGNESIUM STEARATE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
SILICON DIOXIDE 
ETHYLCELLULOSES 
FERRIC OXIDE YELLOW 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITE, YELLOWScoreno score
ShapeCAPSULE (bilayer) Size17mm
FlavorImprint Code724
Contains    
Packaging
#Item CodePackage Description
1NDC:47335-724-8330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2NDC:47335-724-941 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:47335-724-992 BLISTER PACK in 1 CARTON
310 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
4NDC:47335-724-953 BLISTER PACK in 1 CARTON
410 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
5NDC:47335-724-662 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
6NDC:47335-724-754 BLISTER PACK in 1 CARTON
65 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
7NDC:47335-724-646 BLISTER PACK in 1 CARTON
75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081803/01/2018
Labeler - Sun Pharma Global FZE (864347344)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(47335-724), MANUFACTURE(47335-724)

 
Sun Pharma Global FZE

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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