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
  • 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 USP10 mg

OTC - PURPOSE SECTION

Antihistamine

CETIRIZINE HYDROCHLORIDE INDICATIONS AND USAGE

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

WARNINGS

Do not use

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.

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.

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 20⁰ to 25⁰C (68⁰ to 77⁰F)

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