ALLERGY- cetirizine hydrochloride tablet, film coated 
Kroger Company

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692R KROGER 41226 692 Cetirizine Hydrochloride tablets

DRUG FACTS

Cetirizine HCl 10 mg

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
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

Other information

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, titanium dioxide

Questions or comments? 1-800-632-6900

Cetirizine Hydrochloride Tablets 10mg-70ct-Carton

Cetirizine Hydrochloride Tablets 10mg-365ct-Carton

Cetirizine Hydrochloride Tablets 10mg-365ct-Bottle labelCetirizine Hydrochloride tablets 10mg-70ct-Bottle label

ALLERGY 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-692
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
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite ((white to off white)) Scoreno score
ShapeRECTANGLE (Rounded-off rectangular shaped) Size10mm
FlavorImprint Code J;220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-692-651 in 1 CARTON05/11/2021
1365 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41226-692-142 in 1 CARTON05/11/2021
270 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07893305/11/2021
Labeler - Kroger Company (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-692)

Revised: 1/2022
Document Id: d41af1aa-3c12-c440-e053-2a95a90a05fc
Set id: bc020340-ef39-e49a-e053-2a95a90af810
Version: 3
Effective Time: 20220107
 
Kroger Company