Your browser does not support JavaScript! CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

CHILDRENS ZYRTEC (cetirizine hydrochloride) syrup
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 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

  • use only with enclosed dosing cup
adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened; or if bottle wrap or foil inner seal printed with "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

PRINCIPAL DISPLAY PANEL

NDC 50580-730-04

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 - 118 mL Carton
CHILDRENS ZYRTEC 
cetirizine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-730
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg  in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-730-041 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
2NDC:50580-730-092 in 1 PACKAGE, COMBINATION
2118 mL in 1 BOTTLE, PLASTIC
3NDC:50580-730-1512 in 1 CARTON
315 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02215506/01/2009
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 10/2009
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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