CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine HCl 5 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

  • may be taken with or without water
adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if blister unit is open or torn
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, betacyclodextrin, calcium silicate, carmine, colloidial silicon dioxide, disodium inosinate/guanylate, ethyl acetate, FD&C blue no. 2 aluminum lake, flavors, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified cornstarch, sorbitol

Questions?

call 1-800-343-7805

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-720-13

Children's
ZYRTEC®
ALLERGY

Cetirizine HCl/
antihistamine
5 mg chewable tablets

Indoor & Outdoor Allergies

24
hour

Relief of

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

6 yrs.
& older
5 mg each

Grape
Chewables

5
Chewable
Tablets5 mg each

Principal Display Panel
CHILDRENS ZYRTEC 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-720
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
calcium silicate 
silicon dioxide 
ethyl acetate 
FD&C blue no. 2 
aluminum oxide 
lactose monohydrate 
magnesium stearate 
maltodextrin 
mannitol 
cellulose, microcrystalline 
starch, corn 
sorbitol 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUND (Round purple, bilayer tablet) Size8mm
FlavorGRAPEImprint Code Zyrtec;C5
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-720-131 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162101/01/200810/25/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 08/2013
Document Id: 91cb23d6-4c1b-4d7e-b3b6-2a01e4229564
Set id: 4694a68d-238f-4609-a043-ef12c2f58fa8
Version: 2
Effective Time: 20130819
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc