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 v103
SPL
SPL Set ID 9c11dd22-cb17-4179-8c54-1d515bf662d2
Route
ORAL
Published
Effective Date 2025-02-21
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

How Supplied

NDC: 72162-2073-2: 118 mL in a BOTTLE 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 Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

NDC: 72162-2073-2: 118 mL in a BOTTLE

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4

Cetirizine Hydrochloride Oral Solution

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.

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.

Section 51945-4 (51945-4)

Cetirizine Hydrochloride Oral Solution

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)

How Supplied (HOW SUPPLIED)

NDC: 72162-2073-2: 118 mL in a BOTTLE

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

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:36.236767 · Updated: 2026-03-14T23:07:39.601528