Childrens Cetirizine Hydrochloride Solution
FDA Label NDC 17856-6765

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Childrens Cetirizine Hydrochloride (NDC 17856-6765). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Cetirizine HCl 5 mg

Purpose

Antihistamine

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

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.

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.

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

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:

•if breast-feeding: not recommended

•if pregnant: ask a health professional before use.

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)

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 Information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or if printed neckband is broken or missing
  • see bottom panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions Or Comments?

1-800-616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package/Label Principal Display Panel

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

ALLERGY

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing / Runny Nose

Itchy, Watery Eyes / Itchy Throat or Nose

2yrs & older

Dosing Cup Included

Dye-Free

Sugar-Free

Grape Flavored Syrup

* Please review the disclaimer below.