CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride capsule 
KROGER COMPANY

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Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCI USP 10 mg

Purpose

Antihistamine

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

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

  • 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 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 a Poison Control Center right away. (1-800-222-1222)

Directions


adults and children
6 years and over
one 10 mg capsule once daily;
do not take more than one 10 mg
capsule 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

  • store at 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Inactive ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

1-800-632-6900


DISTRIBUTED BY THE KROGER CO.,
CINCINNATI, OHIO 45202

 

MADE IN INDIA

Code: TS/DRUGS/14/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)

NDC 30142-169-53
Kroger®
ORIGINAL PRESCRIPTION STRENGTH
Allergy
Cetirizine HCl Capsules, 10 mg
Antihistamine
INDOOR & OUTDOOR ALLERGIES
24
HOUR
RELIEF

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

25
LIQUID GELS**
**liquid-filled capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)
 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (25's Capsule Container Carton Label)

COMPARE TO the active ingredient
of ZYRTEC®*See back panel
                NDC 30142-169-53

Kroger®
ORIGINAL
PRESCRIPTION
STRENGTH

Allergy
Cetirizine HCl Capsules,
10 mg
Antihistamine
INDOOR & OUTDOOR
ALLERGIES

24 HOURRELIEF OF:

Sneezing, Runny Nose ; Itchy,
Watery Eyes & Itchy Throat
or Nose

CZ10
actual size

24
HOUR
RELIEF

25
LIQUID GELS**
** liquid-filled capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (25's Capsule Container Carton Label)

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-169
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorYELLOW (Clear colourless to pale yellow viscous liquid) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code CZ10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-169-531 in 1 CARTON03/24/202104/01/2022
125 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:30142-169-121 in 1 CARTON03/24/202105/01/2022
240 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910703/24/202105/01/2022
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(30142-169) , MANUFACTURE(30142-169)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(30142-169) , MANUFACTURE(30142-169)

Revised: 1/2024
 
KROGER COMPANY