Cetirizine Hydrochloride (cetirizine hydrochloride 5 mg) Dailymed

Active Ingredient (in Each Chewable Tablet)

For 5 mg:Cetirizine hydrochloride, USP 5 mg For 10 mg:Cetirizine hydrochloride, USP 10 mg

Purpose

Antihistamine

Uses

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 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.

Keep Out Of Reach Of Children

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

Directions

• may be taken with or without water
• chew or crush tablets completely before swallowing

For 5 mg:

adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

adults and children 6 years and over	Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet(10 mg) in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

• store between 20° to 25°C (68° to 77°F)
• do not use if inner safety seal is open or torn
• see top layer for lot number and expiration date

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

Package Label.principal Display Panel

For 5 mg Allergy: Original Prescription Strength NDC 47335-343-83 Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor No Water Needed 30 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD.

Package Label.principal Display Panel

For 10 mg Allergy: Original Prescription Strength NDC 47335-344-83 Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor No Water Needed 30 CHEWABLE TABLETS SUN PHARMA