Fexofenadine

Wockhardt USA LLC.
Wockhardt USA LLC.

Fexofenadine Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Fexofenadine Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding
• Keep out of reach of children
• Directions
• Fexofenadine Other information
• Inactive ingredients
• Questions or comments?
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Fexofenadine Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing                    
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

●   to prevent hives from any known cause such as:

• foods
• insect stings
• medicines
• latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

●   If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• kidney disease. Your doctor should determine if you need a different dose.
• hives that are an unusual color, look bruised or blistered
• hives that do not itch

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 a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve after 3 days of treatment
• the hives have lasted more than 6 weeks

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

For 30 mg:

For 60 mg:

For 180 mg:

Fexofenadine Other information

• safety sealed: do not use if carton is open or if individual blister unit is torn or open
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call toll-free 1-800-346-6854

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL