CETIRIZINE HCL- cetirizine hcl capsule 
KROGER COMPANY

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Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 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

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.

Directions

adults and children 6 years and overone 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

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

call toll free 1-800-632-6900

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*ZYRTEC ®IS A REGISTERED TRADEMARK OF MCNEIL CONSUMER HEALTHCARE, FORT WASHINGTON, PA 19034. MCNEIL CONSUMER HEALTHCARE IS NOT AFFILIATED WITH KROGER CO. OR THIS PRODUCT.

DISTRIBUTED BY

THE KROGER CO.,

CINCINNATI, OHIO 45202 QUALITY GUARANTEE

L0000158

R0319

Principal Display Panel

COMPARE to the active ingredient of ZYRTEC® *See back panel

Kroger

All Day Allergy

Cetirizine Hydrochloride Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

25 SOFTGELS**

(**liquid-filled capsules)

24 HOUR SYMPTOM RELIEF

Cetirizine 25 ct

BACK

CETIRIZINE HCL 
cetirizine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-995
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize13mm
FlavorImprint Code CE1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-995-251 in 1 CARTON06/03/2019
125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:30142-995-401 in 1 CARTON06/03/2019
240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:30142-995-501 in 1 CARTON06/03/2019
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02242906/03/2019
Labeler - KROGER COMPANY (006999528)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(30142-995)

Revised: 3/2020
Document Id: a14e5c93-e190-2d89-e053-2995a90a6419
Set id: 63ddeea4-d701-42b2-bcb7-81c0e43eb013
Version: 2
Effective Time: 20200320
 
KROGER COMPANY