FDA Label for Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each tablet)

Fexofenadine Hydrochloride USP 180 mg
Pseudoephedrine Hydrochloride USP 240 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)
• the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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

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

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 - fexopsedo fig1