Cetirizine Hydrochloride
FDA Label NDC 49348-389

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunmark for the product Cetirizine Hydrochloride (NDC 49348-389). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist if you are, when using this product, stop use and ask a 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 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

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 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

  • 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

sunmark®

COMPARE TO ZYRTEC® ACTIVE INGREDIENT*

NDC 49348-389-13

24 hour

all day allergy

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour relief of: sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

Original Prescription Strength

90 TABLETS 10 mg EACH

Distributed By McKesson

5101725/R0313

90's Bottle Carton (Cetirizine)

90's Bottle Carton (Cetirizine)

* Please review the disclaimer below.