Cetirizine Hydrochloride Tablet
FDA Label NDC 68998-939

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Cetirizine Hydrochloride (NDC 68998-939). 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, 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:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

Active Ingredient (In Each Tablet)

Cetirizine HCl, 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

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

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25°C (68° to 77° F)

Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

call 1-800-406-7984

Principal Display Panel - 10 Mg Tablet Bottle Carton

Compare to the active
ingredient in Zyrtec®*

Marc's®

Indoor/Outdoor

Original Prescription Strength

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg / Antihistamine

Allergy

24
Hour

Relief of:

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

    • 30 TABLETS 10 mg EACH

    Principal Display Panel (10 mg Tablet Bottle Carton)

    Principal Display Panel (10 mg Tablet Bottle Carton)

* Please review the disclaimer below.