Children's Zyrtec Chewable Tablets 2.5mg

Children's Zyrtec Chewable Tablets 2.5mg
SPL v3
SPL
SPL Set ID 0adb3617-3528-4d64-a9ad-b4545ec9d7b9
Route
ORAL
Published
Effective Date 2025-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (2.5 mg)
Inactive Ingredients
Betadex Zea Mays (corn) Starch Lactose Monohydrate Magnesium Stearate Mannitol Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: CTZ Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
NDA Active Since 2021-06-21

Description

Drug Facts

Purpose

Antihistamine

How Supplied

Product: 50090-6845 NDC: 50090-6845-0 6 TABLET, CHEWABLE in a BLISTER PACK / 4 in a CARTON


Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-6845

NDC: 50090-6845-0 6 TABLET, CHEWABLE in a BLISTER PACK / 4 in a CARTON

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
    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
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

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
Cetirizine Hydrochloride
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 2.5 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
    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
Questions?

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

How Supplied (HOW SUPPLIED)

Product: 50090-6845

NDC: 50090-6845-0 6 TABLET, CHEWABLE in a BLISTER PACK / 4 in a CARTON

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

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
Cetirizine Hydrochloride (Cetirizine hydrochloride)
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 2.5 mg


Advanced Ingredient Data


Raw Label Data

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