Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved 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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(s) (in each extended-release tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg
Inactive Ingredients
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.
Strengths
60 mg 120 mg
Quantities
30 tablets
Treats Conditions
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
Pill Appearance
Shape: capsule Color: white Imprint: 724

Identifiers & Packaging

Container Type BOX
UPC
0347335724837
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

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

Package Descriptions
  • 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

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings
Purpose

Purpose Antihistamine Nasal Decongestant

Do Not Use

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

When Using

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 & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Storage & Handling

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) Meets dissolution test 6


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