Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE AUROHEALTH LLC FDA Approved 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
FunFoxMeds box
Route
ORAL
Applications
ANDA213557
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each tablet) Cetirizine hydrochloride USP 10 mg
Inactive Ingredients
Inactive ingredients betadex citric acid anhydrous colloidal silicon dioxide crospovidone dl-alpha-tocopherol hydroxypropyl cellulose magnesium stearate maize maltodextrin mannitol microcrystalline cellulose natural flavourings sodium bicarbonate sodium starch glycolate and sucralose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road East Windsor NJ 08520 Made in India Code: AP/DRUGS/04/2016
Strengths
10 mg
Treats Conditions
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
Pill Appearance
Shape: round Color: white Imprint: CE;10

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
64O047KTOA
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton NDC 58602-862-76 PrimaryHealth *Compare to the active ingredient of Zyrtec ® Allergy Original Prescription Strength Cetirizine Hydrochloride Orally Disintegrating Tablets, USP 10 mg Antihistamine Allergy Dissolve Tabs Indoor + Outdoor Allergies 24 Hour Relief of : Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Melts In Your Mouth ORANGE FLAVOR Actual Size 24 Orally Disintegrating Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton NDC 58602-862-76 PrimaryHealth *Compare to the active ingredient of Zyrtec ® Allergy Original Prescription Strength Cetirizine Hydrochloride Orally Disintegrating Tablets, USP 10 mg Antihistamine Allergy Dissolve Tabs Indoor + Outdoor Allergies 24 Hour Relief of : Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Melts In Your Mouth ORANGE FLAVOR Actual Size 24 Orally Disintegrating Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions Tablet melts in mouth. Can be taken with or without water. 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

Warnings & Precautions
Warnings
Purpose

Purpose Antihistamine

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.

When Using

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 & Ask a Doctor

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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Storage & Handling

Other information store between 20° to 25°C (68° to 77°F). Avoid high humidity. do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date


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