Cetirizine Hydrochloride

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CETIRIZINE
Cetirizine Hydrochloride

Cetirizine Hydrochloride CETIRIZINE AMNEAL PHARMACEUTICALS LLC FDA Approved INDICATIONS AND USAGE 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

Generic: CETIRIZINE

Mfr: AMNEAL PHARMACEUTICALS LLC FDA OTC

Substance Cetirizine Hydrochloride

Route

ORAL

Applications

ANDA078780

Product NDC

65162-0046-00 65162-0046-03 65162-0046-50

Package NDC

65162-046-03 65162-046-50

Drug Facts

Composition & Profile

Active Ingredients

ACTIVE INGREDIENT (in each tablet) Cetirizine HCl USP 10 mg

Inactive Ingredients

INACTIVE INGREDIENT Inactive ingredients lactose monohydrate magnesium stearate polyvinyl alcohol polyethylene glycol povidone starch talc and titanium dioxide.

Strengths

10 mg

Treats Conditions

Indications And Usage 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

Pill Appearance

Shape: oval Color: white Imprint: IP;46

Identifiers & Packaging

Container Type BOX

NDC 65162-0046-00

All Product Codes

65162-0046-00 65162-0046-03 65162-0046-50

UNII

64O047KTOA

SPL Set IDs

273172b2-9aaf-46fb-a1ce-2961650eacd3

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton

Package Descriptions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton

Overview

INDICATIONS AND USAGE 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

Indications & Usage

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

Dosage & Administration

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 over Ask a doctor Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor

Warnings & Precautions

WARNINGS 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.

Purpose

PURPOSE Antihistamine

Stop Use & Ask a Doctor

STOP USE Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

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)

Questions

OTC - QUESTIONS Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST