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Zyrtec Syrup

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

Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.

Drug Facts

Active ingredient (in each 5 mL)

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
  • find right dose on chart below
  • mL = milliliter
adults and children 6 years and over 5 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 over 5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age 2.5 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 age ask 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 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

CHILDRENS ZYRTEC
cetirizine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-730
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
propylene glycol
water
sodium benzoate
SORBITOL SOLUTION
sucralose
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:50580-730-05 1 BOTTLE, PLASTIC in 1 CARTON
1 118 mL in 1 BOTTLE, PLASTIC
2 NDC:50580-730-06 2 CARTON in 1 PACKAGE
2 1 BOTTLE, PLASTIC in 1 CARTON
2 118 mL in 1 BOTTLE, PLASTIC
3 NDC:50580-730-01 1 BOTTLE, PLASTIC in 1 CARTON
3 30 mL in 1 BOTTLE, PLASTIC
4 NDC:50580-730-17 3 TRAY in 1 PACKAGE
4 1 BOTTLE in 1 TRAY
4 118 mL in 1 BOTTLE
5 NDC:50580-730-18 2 CARTON in 1 PACKAGE
5 1 BOTTLE in 1 CARTON
5 118 mL in 1 BOTTLE
6 NDC:50580-730-19 1 BOTTLE, PLASTIC in 1 CARTON
6 240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022155 06/01/2009
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Frequently asked questions

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