Cetirizine Hydrochloride
FDA Label NDC 40032-653

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Novel Laboratories, Inc. for the product Cetirizine Hydrochloride (NDC 40032-653). 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 chewable tablet, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient In Each Chewable Tablet

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 10 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

Warnings

Do not use if you have ever had an allergic reactions 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 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 The Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

  • may be taken with or without water
  • For Cetirizine Hydrochloride Chewable Tablets, 5 mg

    adults and children 6 years
    1 to 2 tablets once daily depending upon severity of symptoms; do not take
    and over
    more than 2 tablets in 24 hours.
    adults 65 years and over
    1 tablet once a day; do not take more than 1 tablet in 24 hours


    children under 6 years of
    ask a doctor
    age

    consumers with liver or
    ask a doctor
    kidney disease

    For Cetirizine Hydrochloride Chewable Tablets, 10 mg

    adults and children 6
    one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
    years and over
    5 mg product may be appropriate for less severe symptoms.
    adults 65 years and
    ask a doctor
    over

    children under 6 years of age
    ask a doctor
    consumers with liver
    ask a doctor
    or kidney disease

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Do not use if individual blister unit is open or torn

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor

Questions

Call 1-866-403-7592

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Package Label.Principal Display Panel

For 5 mg Allergy:

NDC 40032-653-03

Children's

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

30 CHEWABLE TABLETS

Container Label

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C:\users\kvyas\desktop\cetirizine HCl\container 2.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 02)

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C:\users\kvyas\desktop\cetirizine HCl\container 3.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 03)

Container Carton

C:\users\kvyas\desktop\cetirizine HCl\container Carton.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 04)

C:\users\kvyas\desktop\cetirizine HCl\container Carton.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 04)

For 10 mg Allergy:

NDC 40032-652-31

Children's

Cetirizine Hydrochloride Chewable Tablets

10 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

Blister Label

C:\users\kvyas\desktop\cetirizine HCl\blister.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 05)

C:\users\kvyas\desktop\cetirizine HCl\blister.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 05)

Blister Carton

NDC 40032-652-30

C:\users\kvyas\desktop\cetirizine HCl\blistercarton Front.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 06)

C:\users\kvyas\desktop\cetirizine HCl\blistercarton Front.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 06)

C:\users\kvyas\desktop\cetirizine HCl\blistercarton Back.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 07)

C:\users\kvyas\desktop\cetirizine HCl\blistercarton Back.jpg (Bfdecffe 0828 4cff 85d3 75d36e0b922e 07)

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