CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable 
Johnson & Johnson Consumer Inc.

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Children's Zyrtec Chewable Tablets 2.5mg

Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine HCl 2.5 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

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

NDC 50580-790-01

Children's

ZYRTEC ®

Cetirizine HCl chewable tablets,

2.5 mg/antihistamine

ALLERGY

INDOOR + OUTDOOR

ALLERGIES

Dye-Free

Chewables

24

HOUR

RELIEF OF

2 yrs.

& older

Grape Flavor

Actual

Size

2.5 mg

12 Chewable Tablets

Chew or crush tablets completely

before swallowing

Zyrtec-01

CHILDRENS ZYRTEC 
cetirizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-790
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE2.5 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
ShapeROUNDSize8mm
FlavorGRAPEImprint Code CTZ
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-790-012 in 1 CARTON06/21/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-790-024 in 1 CARTON06/21/2021
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-790-031 in 1 CARTON09/01/2022
36 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 - Johnson & Johnson Consumer Inc. (878046358)

Revised: 3/2023
Document Id: f7b5e3b5-fc58-e72f-e053-6294a90aa1e4
Set id: 013ce40e-37c9-4b84-b530-ed895f60ce0e
Version: 5
Effective Time: 20230325
 
Johnson & Johnson Consumer Inc.