CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable
Johnson & Johnson Consumer Inc.

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Children's Zyrtec Chewable Tablets 10mg

Drug Facts

Active ingredient (in each chewable 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

may be taken with or without water
chew or crush tablets completely before swallowing

adults and children 6 years and over	Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 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

Original Prescription Strength

NDC 50580-791-01

Children's
ZYRTEC ®

Cetirizine HCl chewable tablets,
10 mg/antihistamine

ALLERGY

INDOOR + OUTDOOR
ALLERGIES

Dye-Free
Chewables

24
HOUR
RELIEF OF

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

6yrs.
& older
Grape Flavor

Actual
Size

Chew or crush tablets completely
before swallowing

10 mg
24 Chewable Tablets

CHILDRENS ZYRTEC
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-791
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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	12mm
Flavor	GRAPE	Imprint Code	CTZ;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50580-791-01	4 in 1 CARTON	06/21/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50580-791-03	1 in 1 CARTON	09/01/2022
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50580-791-02	8 in 1 CARTON	01/01/2023
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:50580-791-72	3 in 1 CARTON	01/15/2024
4		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024

Document Id: 0e939452-59b2-27fc-e063-6394a90a780c

Set id: 0fe77356-d945-46a0-882e-b3bbab784556

Version: 8

Effective Time: 20240110

Johnson & Johnson Consumer Inc.