Cetirizine Hydrochloride Tablet
FDA Label NDC 85293-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Umasuto, Llc for the product Cetirizine Hydrochloride (NDC 85293-001). 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 pupose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, when using this product, otc - stop use, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Pupose

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 Useif 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 haveliver 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 aretaking tranquilizers or sedatives.

When Using This Product

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

Otc - Stop Use

Stop use and ask a doctorif 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 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 sever 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 at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-768-0551

Other

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Umasuto, LLC

14130 Minnesota Avenue, Bonner Springs,

KS 66012

Issued 03/2025

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