Active Ingredient(S)
(in each extended-release tablet)
Fexofenadine HCl, USP 60 mg
Pseudoephedrine HCl, USP 120 mg
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
FDA Label NDC 47335-724
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 47335-724). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 Spl-fexofenadine-label1 (Spl Fexofenadine Label1) Spl-fexofenadine-label2 (Spl Fexofenadine Label2) Spl-fexofenadine-label3 (Spl Fexofenadine Label3)
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 Spl-fexofenadine-showbox (Spl Fexofenadine Showbox)
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 
* Please review the disclaimer below.
