Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor) Important: Read all product information before using. Keep this box for important information. This product is intended for use in children. DRUG FACTS

Manufacturer
Bryant Ranch Prepack
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
104
Source
full-release
Hydrated at
2026-06-01 01:51:02

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

Directions And Dosage

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

Other Label Information

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

Questions?

Call 1-888-344-9603 (toll-free)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hcl 1mg/ml Oral Solution #118

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

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 INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-888-344-9603 (toll-free)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 51001 & 51002 Rev. 10/18

HOW SUPPLIED

How Supplied Section

Cetirizine HCl 5 mg 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 Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hcl 1mg/ml Oral Solution #118

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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