FDA Label for Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Drug Facts

Active ingredients (in each 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)
• 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 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 carton is opened or if individual blister units are torn or opened. 
• store at 20-25°C (68-77°F).
• Meets USP dissolution test 7

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

DISTRIBUTED BY
CARDINAL HEALTH,
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

Made in India

Package Label-Principal Display Panel - 2X10 Blister Carton

LEADER_™

NDC 70000-0677-1

NON-DROWSY

12HR Allergy & Congestion Relief

Fexofenadine HCl 60 mg | Pseudoephedrine HCl 120 mg
Extended-Release Tablets, USP
Antihistamine | Nasal Decongestion

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    

Actual Size

COMPARE TO
ALLEGRA-D^®
12 HOUR ALLERGY
& CONGESTION TABLETS
active ingredients*

20 EXTENDED-RELEASE
     TABLETS

fexofenadine-fig1 - fexofenadine fig1