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Childrens Zyrtec Allergy by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, orally disintegrating
Ingredients: Cetirizine Hydrochloride 10mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-782

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:

  • 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

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
  • store between 20° to 25°C (68° to 77°F). Avoid high humidity.
  • do not use if carton or blister unit is opened or broken

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

Indoor + Outdoor
Allergies

Children's
ZyRTEC® ALLERGY

Cetirizine HCl orally disintegrating tablets
10mg/antihistamine

Dissolve Tabs

6 yrs.
& older
10mg each

Citrus Flavor

24
hour

Relief of

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

Actual
Size

CHILDRENS ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-782
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer 
anhydrous citric acid 
silicon dioxide 
crospovidone (15 MPA.S AT 5%) 
hydroxypropyl cellulose (80000 MW) 
magnesium stearate 
mannitol 
microcrystalline cellulose 
sodium bicarbonate 
sodium starch glycolate Type A Potato 
sucralose 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorCITRUSImprint CodeZ10
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-782-122 BLISTER PACK in 1 CARTON
16 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
2NDC:50580-782-244 BLISTER PACK in 1 CARTON
26 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
3NDC:50580-782-012 CARTON in 1 PACKAGE
34 BLISTER PACK in 1 CARTON
36 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02257801/20/2014
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 11/2016
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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