cetirizine hydrochloride

Unichem Pharmaceuticals (USA), Inc.

Cetirizine Hydrochloride Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• OTC - ACTIVE INGREDIENT SECTION
  • For 5 mg
  • For 10 mg
• OTC - PURPOSE SECTION
• CETIRIZINE HYDROCHLORIDE INDICATIONS AND USAGE
• WARNINGS
  • Severe Allergy Warning
  • Not a Substitute for Epinephrine.
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding:
• OTC - KEEP OUT OF REACH OF CHILDREN
• CETIRIZINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION
  • For 5 mg
  • For 10 mg
• STORAGE AND HANDLING
• INACTIVE INGREDIENT
• OTC - QUESTIONS
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

(IN EACH TABLET)

For 5 mg

Cetirizine HCl USP 5 mg

For 10 mg

Cetirizine HCl USP 10 mg

OTC - PURPOSE SECTION

Antihistamine

CETIRIZINE HYDROCHLORIDE INDICATIONS AND USAGE

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 occuring. 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 or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

• liver or 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.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness.
• be careful when driving a motor vehicle or operating machinery.

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:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

CETIRIZINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION

For 5 mg

For 10 mg

STORAGE AND HANDLING

• store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENT

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide

OTC - QUESTIONS

call 1-866-562-4616

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India

Distributed by:

Rochelle Park, NJ 07662.

PRINCIPAL DISPLAY PANEL