Children'sCetirizine Hydrochloride Chewable TabletsAntihistamine Drug Facts

Active Ingredient (in each chewable tablet)

Cetirizine Hydrochloride 5 mg Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Uses:

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:

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by 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.

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

Do not use

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.

• to prevent hives from any known cause such as:
•  foods
•  insect stings
•  medicines
•  latex or rubber gloves

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 transquillizers 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 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions:

●  may be taken with and without water

For Cetirizine Hydrochloride Chewable Tablets 5 mg 

Cetirizine Hydrochloride Chewable Tablets 10 mg 

Other information:

• store between 20º to 25º C (68º to 77º F).
• Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg
• Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg
• do not use if carton is opened or if blister unit is broken.
• see bottom panel for lot number and expiration date.

Inactive ingredients:

acesulfame potassium, artificial & natural flavors,aspartame, betadex, colloidal silicon dioxide, croscarmellose sodium, dl-alpha-tocopherol, ethyl cellulose, FD&C yellow # 6 aluminum lake, fumaric acid, hypromellose, magnesium stearate, mannitol, maltodextrin, microcrystalline cellulose and talc.

Questions? call 1-800-313-4623

Manufactured by:Jubilant Generics Ltd.Roorkee-247661, India

Marketed by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USA

Revised : November / 2014