Cetirizine Hydrochloride Tablet, Chewable
FDA Label NDC 51660-066

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ohm Laboratories Inc. for the product Cetirizine Hydrochloride (NDC 51660-066). 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 chewable 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:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Active Ingredient (In Each Chewable 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

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.

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

  • may be taken with or without water
  • chew or crush tablets completely before swallowing
    • adults and children 6 years and overChew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

  • store between 20° to 25°C (68° to 77°F)
  • do not use if inner safety seal is open or torn
  • see side panel for lot number and expiration date

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel - 10 Mg Tablet Bottle Carton

†Compare To
the active ingredient of
Children's Zyrtec®

NDC 51660-066-30

ohm®

Original Prescription Strength

Cetirizine
Hydrochloride
Chewable
Tablets 10 mg

Antihistamine

Allergy

Tutti-frutti Flavor
No Water Needed

Indoor + Outdoor Allergies

Actual Size

24 Hour Relief of:

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

    • 30 CHEWABLE
    TABLETS

    Principal Display Panel (10 mg Tablet Bottle Carton)

    Principal Display Panel (10 mg Tablet Bottle Carton)

* Please review the disclaimer below.