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Zyrtec Capsule

Pronunciation

Generic Name: cetirizine hydrochloride
Dosage Form: capsule, liquid filled

Zyrtec®

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

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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 capsule once daily; do not take more than one 10 mg capsule 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 at 20° - 25°C (68° - 77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if foil inner seal printed with "Safety Seal®" is broken or missing

Inactive ingredients

gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-779-40

ZYRTEC ®
ALLERGY

NEW
LIQUID GELS

Cetirizine HCl/
antihistamine
10 mg capsules

INDOOR + OUTDOOR
ALLERGIES

LIQUID
GELS

24
HOUR
RELIEF OF

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

40
LIQUID GELS*
*LIQUID-FILLED CAPSULES
10 mg each

ZYRTEC 
cetirizine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-779
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 10 mg
Product Characteristics
Color YELLOW (Clear) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code Z10
Contains         
Packaging
# Item Code Package Description
1 NDC:50580-779-12 1 BOTTLE (BOTTLE) in 1 PACKAGE
1 12 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2 NDC:50580-779-25 1 BOTTLE (BOTTLE) in 1 PACKAGE
2 25 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
3 NDC:50580-779-40 1 BOTTLE (BOTTLE) in 1 PACKAGE
3 40 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
4 NDC:50580-779-65 65 CAPSULE, LIQUID FILLED (CAPSULE) in 1 PACKAGE, COMBINATION
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 02/08/2010
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 12/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc



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