Children's Cetirizine Hydrochloride Oral Solution, Usp 1 Mg/ml (bubble Gum & Grape Flavor)

Children's Cetirizine Hydrochloride Oral Solution, Usp 1 Mg/ml (bubble Gum & Grape Flavor)
SPL v9
SPL
SPL Set ID 9163cd2e-0be7-4009-b905-729014773d6e
Route
ORAL
Published
Effective Date 2025-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (1 mg)
Inactive Ingredients
Anhydrous Citric Acid Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-10-15
Description

Cetirizine HCl 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 5 mg

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

Manufactured by:

Quagen Pharmaceuticals LLC

West Caldwell, NJ 07006



51001 & 51002

Rev. 10/18

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.
  • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.
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
  • 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 over  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 1-888-344-9603 (toll-free)

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • Protect from light
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients

Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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

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.

Principal Display Panel Grape Flavor Carton Label

Principal Display Panel Grape Flavor Container Label

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)

Manufactured by:

Quagen Pharmaceuticals LLC

West Caldwell, NJ 07006



51001 & 51002

Rev. 10/18

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.
  • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.
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
  • 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 over  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 1-888-344-9603 (toll-free)

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • Protect from light
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Principal Display Panel Grape Flavor Carton Label (PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label)

Principal Display Panel Grape Flavor Container Label (PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.967786 · Updated: 2026-03-14T23:11:54.825001