Zyrtec

Generic Name: cetirizine hydrochloride
Dosage Form: tablet, film coated
Zyrtec®

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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 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.

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

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 imprinted foil inner seal on bottle is broken or missing

Inactive ingredients

carnauba wax, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-729-45

Zyrtec®ALLERGY

Cetirizine HCl/
antihistamine
10 mg tablets

Indoor & Outdoor Allergies

24
hour

Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

45
Tablets
10 mg each

Zyrtec  cetirizine hydrochloride  tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-729 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 10 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code Zyrtec;10;MG Contains

Packaging # NDC Package Description Multilevel Packaging 1 50580-729-01 1 TABLET In 1 POUCH None 2 50580-729-02 1 TABLET In 1 POUCH None 3 50580-729-03 50 POUCH In 1 CARTON contains a POUCH (50580-729-02) 3 50580-729-02 1 TABLET In 1 POUCH This package is contained within the CARTON (50580-729-03) 4 50580-729-05 5 BLISTER PACK In 1 PACKAGE contains a BLISTER PACK 4 1 TABLET In 1 BLISTER PACK This package is contained within the PACKAGE (50580-729-05) 5 50580-729-13 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 1 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-729-13) 6 50580-729-14 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 6 14 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-14) 7 50580-729-30 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 7 30 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-30) 8 50580-729-45 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 8 45 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-45) 9 50580-729-50 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 9 50 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-50) 10 50580-729-51 2 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 10 50 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-51) 11 50580-729-70 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 11 70 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-70) 12 50580-729-90 1 BOTTLE In 1 PACKAGE contains a BOTTLE, PLASTIC 12 90 TABLET In 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (50580-729-90)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019835	01/01/2008

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 11/2009McNeil Consumer Healthcare Div McNeil-PPC, Inc