Fexofenadine (fexofenadine hydrochloride 180 mg) Dailymed

Spl Listing Data Elements Section

Spl Listing Data Elements Section

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

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 bulered
• 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:

adults and children 12 years of age and over	take two 30 mg tablets with water every 12 hours;do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours;do not take more than 2 tablets in 24 hours
children under 6 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

For 60 mg:

adults and children 12 years of age and over	take one 60 mg tablet with water every 12 hours;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

For 180 mg:

adults and children 12 years of age and over	take one 180 mg tablet with water once a day;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 open or if individual buler 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

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