Cetirizine Hydrochloride Solution
FDA Label NDC 70752-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quagen Pharmaceuticals Llc for the product Cetirizine Hydrochloride (NDC 70752-103). 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, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding:, directions, 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)

→ Purpose

→ Uses

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ If Pregnant Or Breast-feeding:

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - Bubble Gum Flavor - Container Label

→ Principal Display Panel - Bubble Gum Flavor - Carton Label

→ Principal Display Panel - Grape Flavor - Container Label

→ Principal Display Panel - Grape Flavor-carton Label

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

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

If Pregnant Or Breast-Feeding:

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

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)
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