Children's Zyrtec Chewable Tablets 10mg

SPL v12

SPL

SPL Set ID 0fe77356-d945-46a0-882e-b3bbab784556

Route

ORAL

Published

Effective Date 2025-04-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Betadex Starch, Corn Lactose Monohydrate Magnesium Stearate Mannitol Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: CTZ;10 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

NDA Active Since 2021-06-21

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

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.

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

Questions?

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

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

Principal Display Panel

New Look Same relief

Original Prescription Strength

NDC 50580-791-01

Children's

ZYRTEC ^®

Cetirizine HCl chewable tablets,

10 mg/antihistamine

ALLERGY

Indoor +

Outdoor

Allergies

6yrs

& older

Dye-Free

Chewables

24 Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

ActualSize

Grape Flavor

Chew or crush tablets

completely before swallowing

24 CHEWABLE TABLETS

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

If Pregnant Or Breast Feeding

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

Active Ingredient (in Each Chewable Tablet)

Cetirizine HCl 10 mg

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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.

Purpose

Antihistamine

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

Questions?

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

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if blister unit is torn or broken

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

New Look Same relief

Original Prescription Strength

NDC 50580-791-01

Children's

ZYRTEC ^®

Cetirizine HCl chewable tablets,

10 mg/antihistamine

ALLERGY

Indoor +

Outdoor

Allergies

6yrs

& older

Dye-Free

Chewables

24 Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

ActualSize

Grape Flavor

Chew or crush tablets

completely before swallowing

24 CHEWABLE TABLETS

When Using This Product (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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Cetirizine HCl 10 mg

Advanced Ingredient Data

[{"name": "BETADEX", "unii": "JV039JZZ3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "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)", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "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.", "Purpose": "Antihistamine", "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", "Questions?": "call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)", "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", "PRINCIPAL DISPLAY PANEL": "New Look Same relief Original Prescription Strength NDC 50580-791-01 Children's ZYRTEC ® Cetirizine HCl chewable tablets, 10 mg/antihistamine ALLERGY Indoor + Outdoor Allergies 6yrs & older Dye-Free Chewables 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose ActualSize Grape Flavor Chew or crush tablets completely before swallowing 24 CHEWABLE TABLETS", "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", "If pregnant or breast-feeding": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "Active ingredient (in each chewable tablet)": "Cetirizine HCl 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.239850 · Updated: 2026-03-14T23:08:17.487612