Cetirizine Hydrochloride
FDA Label NDC 49035-652

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Cetirizine Hydrochloride (NDC 49035-652). 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.

Label Section Quick Index

Active Ingredient In Each Chewable Tablet

Cetirizine Hydrochloride Chewable Tablets 10mg

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
    • 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)
  • 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

1-888-287-1915

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