CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable 
Kenvue Brands LLC

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Children's Zyrtec Chewable Tablets 10mg

Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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 overChew 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

betadex, corn starch, flavor, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-791-01

Children's
ZYRTEC ®

Cetirizine HCl chewable tablets,
10 mg/antihistamine

ALLERGY

INDOOR + OUTDOOR
ALLERGIES

Dye-Free
Chewables

24
HOUR
RELIEF OF

6yrs.
& older
Grape Flavor

Actual
Size

Chew or crush tablets completely
before swallowing

10 mg
24 Chewable Tablets

PRINCIPAL DISPLAY PANEL
CHILDRENS ZYRTEC 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-791
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
BETADEX (UNII: JV039JZZ3A)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorGRAPEImprint Code CTZ;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-791-014 in 1 CARTON06/21/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-791-031 in 1 CARTON09/01/2022
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-791-028 in 1 CARTON01/01/2023
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:50580-791-723 in 1 CARTON01/15/2024
424 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162106/21/2021
Labeler - Kenvue Brands LLC (118772437)

Revised: 11/2024
Document Id: 21b1c3cc-be05-b6a5-e063-6394a90a1e95
Set id: 0fe77356-d945-46a0-882e-b3bbab784556
Version: 10
Effective Time: 20241108
 
Kenvue Brands LLC