Cetirizine Hydrochloride Solution
FDA Label NDC 51672-2106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Cetirizine Hydrochloride (NDC 51672-2106). 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 other, active ingredient (in each 5 ml), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

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

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding:

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

Otc - Keep Out Of Reach Of Children

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 over5 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 over5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age2.5 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 ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information

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

Inactive Ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Questions?

Call 1-866-923-4914

Principal Display Panel - 120 Ml Bottle Carton

Compare to the
active ingredient
in Children's Zyrtec®*

NDC 51672-2106-8

Children's
Cetirizine
Hydrochloride
Oral Solution
1 mg/mL ALLERGY
Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • 2 Yrs. & older

    Bubble Gum
    Flavor

    Dosing Cup Included

    4 FL OZ
    (120 mL)

    Principal Display Panel (120 mL Bottle Carton)

    Principal Display Panel (120 mL Bottle Carton)

* Please review the disclaimer below.