Childrens zyrtec tablet, chewable

Spl unclassified section

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

Otc - do not use section

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Otc - ask doctor section

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking 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

Otc - stop use section

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Otc - pregnancy or breast feeding section

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 section

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

Other information

  • store between 20 to 25C (68 to 77F)
  • 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

Ingredients and appearance - Product information

Childrens zyrtec tablet, chewable- Cetirizine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 50580-720
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium silicate ( UNII: S4255P4G5M)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Ethyl acetate ( UNII: 76845O8NMZ)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Aluminum oxide ( UNII: LMI26O6933)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color PURPLE Score 1
Shape ROUND (Round purple, bilayer tablet) Size 8 mm
Imprint Code Zyrtec;C5 Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021621 USA

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

Principal display panel

Original Prescription Strength

NDC 50580-720-13

Children's
ZYRTEC
®
ALLERGY

Cetirizine HCl/
antihistamine
5 mgchewable 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
Tablets 5 mgeach