CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable

Childrens Zyrtec by

Drug Labeling and Warnings

Childrens Zyrtec by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine HCl 2.5 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

• may be taken with or without water
• chew or crush tablets completely before swallowing
  • children 2 to under 6 years of age: Chew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours.
  • adults and children 6 years and over: Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours.
  • adults 65 years and over: Chew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) 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 blister unit is torn or broken

Inactive ingredients

betadex, corn starch, flavor, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose

Questions?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-790-01

Children's

ZYRTEC ®

Cetirizine HCl chewable tablets,

2.5 mg/antihistamine

ALLERGY

INDOOR + OUTDOOR

ALLERGIES

Dye-Free

Chewables

24

HOUR

RELIEF OF

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

2 yrs.

& older

Grape Flavor

Actual

Size

2.5 mg

12 Chewable Tablets

Chew or crush tablets completely

before swallowing

INGREDIENTS AND APPEARANCE

CHILDRENS ZYRTEC 
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-790
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
BETADEX (UNII: JV039JZZ3A)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor	GRAPE	Imprint Code	CTZ
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-790-01	2 in 1 CARTON	06/21/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-790-02	4 in 1 CARTON	06/21/2021
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-790-03	1 in 1 CARTON	09/01/2022
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021621	06/21/2021

Labeler - Kenvue Brands LLC (118772437)