CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, orally disintegrating 
TOPCO ASSOCIATES LLC

----------

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


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.

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 before use if you are

taking tranquilizers or sedatives.

When using this product

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

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

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

Other information

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:
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
QUESTIONS? 1-888-423-0139

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton

+TopCare®
health

NDC 76162-009-76

COMPARED TO ZYRTEC® ALLERGY
ACTIVE INGREDIENT*

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY

Cetirizine Hydrochloride
ORALLY DISINTEGRATING TABLETS, USP 10 mg
ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR
RELIEF

•    Sneezing         •    Iitchy, Watery Eyes
•    Runny Nose     •    Itchy Throat or Nose


24 ORALLY DISINTEGRATING TABLETS 10 MG EACH
DISSOLVE TABLETS •    MELTS IN YOUR MOUTH  •    ORANGE FLAVOR

actual
size                10




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
BETADEX (UNII: JV039JZZ3A)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorORANGEImprint Code CE;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-009-764 in 1 CARTON06/06/2024
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21355706/06/2024
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(76162-009) , MANUFACTURE(76162-009)

Revised: 6/2024
Document Id: 7baa79c5-be46-4b09-8cae-c306edb7f97a
Set id: f4ba3e0c-e6b3-2596-e053-2a95a90ab850
Version: 2
Effective Time: 20240611
 
TOPCO ASSOCIATES LLC