CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, orally disintegrating 
KROGER COMPANY

----------

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? 
1-800-632-6900


DISTRIBUTED BY
THE KROGER CO.
CINCINNATI,
OHIO 45202
  

MADE IN INDIA

Code: AP/DRUGS/04/2016


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

COMPARE TO the active ingredient of ZYRTEC® ALLERGY *See bottom panel

Kroger®
ORIGINAL
PRESCRIPTION
STRENGTH

NDC 30142-058-76

Allergy
Cetirizine Hydrochloride
Orally Disintegrating Tablets,
USP 10 mg /
Antihistamine

DISSOLVE TABS
INDOOR & OUTDOOR
ALLERGIES

24
HOUR

24 HOUR
RELIEF OF:
Sneezing;
Runny Nose;
Itchy, Watery Eyes;
Itchy Throat or Nose

Orange Flavour
Melts in Your Mouth

actual
size

24 TABLETS
Orally Disintegrating Tablets, 10 mg each



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-058
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:30142-058-764 in 1 CARTON03/08/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21355703/08/2021
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(30142-058) , MANUFACTURE(30142-058)

Revised: 5/2021
Document Id: 013f034c-15f9-4da2-b74c-ac999b276053
Set id: b8b2af96-af48-5f63-e053-2995a90a7d7c
Version: 3
Effective Time: 20210506
 
KROGER COMPANY