Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE AUROHEALTH LLC 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
FunFoxMeds box
Route
ORAL
Applications
ANDA215232

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each tablet) Fexofenadine Hydrochloride USP 180 mg Pseudoephedrine Hydrochloride USP 240 mg
Inactive Ingredients
Inactive ingredients cellulose acetate colloidal silicon dioxide copovidone croscarmellose sodium dibutyl sebacate ferrosoferric oxide glyceryl mono- and di-caprylocaprate hypromellose lactose monohydrate microcrystalline cellulose polyethylene glycol polyvinyl alcohol-part. hydrolyzed propylene glycol shellac sodium lauryl sulfate stearic acid talc and titanium dioxide Questions or Comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Manufactured for: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor NJ 08520 Made in India Code: TS/DRUGS/22/2009
Strengths
180 mg 240 mg
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: round Color: white Imprint: FES

Identifiers & Packaging

Container Type BOX
UNII
2S068B75ZU 6V9V2RYJ8N
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton AUROHEALTH NDC 58602-844-60 * Compare to the active ingredients in Allegra-D ® 24 Hour Allergy & Congestion Tablets Non-Drowsy Allergy & Congestion Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP 180 mg/240 mg Fexofenadine Hydrochloride 180 mg/antihistamine Pseudoephedrine Hydrochloride 240 mg/nasal decongestion 24 HR Indoor / Outdoor Relief Of Nasal and Sinus Congestion Due to Colds or Allergens Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies Actual size 5 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton AUROHEALTH NDC 58602-844-60 * Compare to the active ingredients in Allegra-D ® 24 Hour Allergy & Congestion Tablets Non-Drowsy Allergy & Congestion Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP 180 mg/240 mg Fexofenadine Hydrochloride 180 mg/antihistamine Pseudoephedrine Hydrochloride 240 mg/nasal decongestion 24 HR Indoor / Outdoor Relief Of Nasal and Sinus Congestion Due to Colds or Allergens Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies Actual size 5 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 x 5 Blister Carton

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 24 hours on an empty stomach; do not take more than 1 tablet 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 carton is opened or if individual blister units are torn or opened store between 20° and 25°C (68° and 77°F) FDA approved dissolution test specifications differ from USP

Warnings & Precautions
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
Purpose

Purpose Antihistamine Nasal decongestant

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 ) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions ).

Stop Use & Ask a Doctor

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.

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 (1-800-222-1222) right away.


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