Cetirizine Hydrochloride Tablet
FDA Label NDC 71205-093

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Cetirizine Hydrochloride (NDC 71205-093). 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 ingredients (in each tablet), purpose, uses, do not use, ask doctor, ask doctor/pharmacist, when using this product, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Cetirizine HCl USP 5 mg

Purpose

Antihistimine

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

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 Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking 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.

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.

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 6years and over


1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours


Adults 65 years and over


1 tablet once a day; do not take more than 1 tablet in 24 hours


Children under 6 years of age


Ask a doctor


Consumers with liver or kidney disease


Ask 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 1-866-562-4597

Other

Manufactured by:

Unique Pharmaceutical Labs,

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

Mumbai 400 030, India.

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430      May 2018

120004

Repackaged By;

Proficient Rx LP

Thousand Oaks 91320

Cetirizine Hydrochloride Tablets Usp 5 Mg

NDC 71205-093-30

Original Prescription Strength

Cetirizine Hydrochloride
Tablets 5 mg

30 Tablets

71205-093-30 (Cetirizinelabel 5mg 100count)

71205-093-30 (Cetirizinelabel 5mg 100count)

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