Children's Cetirizine Hydrochloride Oral Solution

Children's Cetirizine Hydrochloride Oral Solution
SPL v2
SPL
SPL Set ID 30cbaa91-2216-efd2-e063-6294a90aaaed
Route
ORAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (1 mg)
Inactive Ingredients
Propylene Glycol Water Sodium Acetate Anhydrous Sucralose Sodium Benzoate Acetic Acid Glycerin

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-03-20
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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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 older 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
Questions?

Call 1-866-923-4914

120 Ml Carton

Compare to the

active ingredient

in Children's Zyrtec ®*

NDC 51672-2147-8

Other Information
  • each 5mL contains:sodium 4 mg
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

artificial grape flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, 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
If Pregnant Or Breast Feeding
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Active Ingredient (in Each 5 Ml)

Cetirizine HCl 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 ifan 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 aretaking tranquilizers or sedatives.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Purpose

Antihistamine

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 older 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
Questions?

Call 1-866-923-4914

120 Ml Carton (120 mL Carton)

Compare to the

active ingredient

in Children's Zyrtec ®*

NDC 51672-2147-8

Other Information (Other information)
  • each 5mL contains:sodium 4 mg
  • do not use if carton is opened or if imprinted safety seal is broken or missing
  • see bottom panel for lot number and expiration date
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

artificial grape flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, 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
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 5 Ml) (Active ingredient (in each 5 mL))

Cetirizine HCl 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:26.368137 · Updated: 2026-03-14T23:12:38.341862