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Zyrtec Syrup Prescribing Information

Package insert / product label
Generic name: cetirizine hydrochloride
Dosage form: children's syrup
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Indications and Usage for Zyrtec Syrup

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)

Zyrtec Syrup Dosage and Administration

  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter
adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Storage and Handling

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate,sorbitol solution, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-730-05

Children's
ZYRTEC
®
ALLERGY

Cetirizine HCl
1 mg /ml oral solution
antihistamine

Indoor & Outdoor Allergies

24
hour
Relief of

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

2 yrs.
& older

Grape
Syrup

Dye-Free • Sugar-Free

4 fl oz (118 ml)
Dosing Cup Included

PRINCIPAL DISPLAY PANEL
CHILDRENS ZYRTEC
cetirizine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-730
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
Product Characteristics
Color Score
ShapeSize
FlavorGRAPEImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-730-051 in 1 CARTON07/13/2015
1118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
2NDC:50580-730-062 in 1 PACKAGE07/31/2015
21 in 1 CARTON
2118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
3NDC:50580-730-011 in 1 CARTON01/16/2017
330 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
4NDC:50580-730-173 in 1 PACKAGE12/03/2018
41 in 1 TRAY
4118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
5NDC:50580-730-182 in 1 PACKAGE12/03/2018
51 in 1 CARTON
5118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
6NDC:50580-730-191 in 1 CARTON06/16/2020
6240 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02215506/01/2009
Labeler - Johnson & Johnson Consumer Inc. (878046358)

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