Cetirizine Hydrochloride Tablet
FDA Label NDC 70000-0047

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Cetirizine Hydrochloride (NDC 70000-0047). 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 tablet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

Active Ingredient (In Each Tablet)

Cetirizine hydrochloride USP 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 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


adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.  A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 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)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?


call 1-855-274-4122

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

Made in India

Code: TS/DRUGS/19/1993

Package Label-Principal Display Panel - 10 Mg (14'S Tablet Blister Pack Label)

LEADERTM

NDC 70000-0047-1

Original Prescription Strength
All Day Allergy
Cetirizine Hydrochloride USP, 10 mg
Tablets Antihistamine

Indoor and 
Outdoor Allergies
24-Hour Relief of :
Sneezing; Runny Nose;Itchy;
Watery Eyes;Itchy throat or nose

365 TABLETS


Package Label-principal Display Panel (10 mg (14's Tablet Blister Pack Label))

Package Label-principal Display Panel (10 mg (14's Tablet Blister Pack Label))

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