CHILDRENS ZYRTEC ALLERGY- cetirizine hydrochloride tablet, orally disintegrating 
Johnson & Johnson Consumer Inc.

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Childrens Zyrtec Allergy

Drug Facts

Active ingredient (in each 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

Tablet melts in mouth. Can be taken with or without water.

adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet 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

amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-782-12

Children's
ZyRTEC ® ALLERGY

Cetirizine HCl

orally disintegrating tablets
10 mg/antihistamine

Indoor + Outdoor
Allergies

Dissolve Tabs

24
hour

Relief of

6 yrs.
& older
10mg each

Citrus Flavor

Actual
Size

Melts In
Your Mouth

12 ORALLY DISINTEGRATING TABLETS

Zyrtec-1

CHILDRENS ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-782
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
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorCITRUSImprint Code Z10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-782-122 in 1 CARTON01/20/2014
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-782-244 in 1 CARTON01/20/2014
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-782-012 in 1 PACKAGE01/20/2014
34 in 1 CARTON
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02257801/20/2014
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 6/2023
Document Id: fbf85f43-1d5f-f9a8-e053-6394a90a3c8b
Set id: a1edc2e6-3661-4d7a-884c-709d73cb89e0
Version: 9
Effective Time: 20230606
 
Johnson & Johnson Consumer Inc.