CETIRIZINE HYDROCHLORIDE (ALLERGY) - cetirizine hydrochloride capsule 
WALGREEN CO.

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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:


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 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

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

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


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200 WILMOT RD., DEERFIELD, IL 60015
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)

ORIGINAL
PRESCRIPTION STRENGTH    
    NDC 0363-0068-53
walgreens
Allergy Relief

24 HOUR ALLERGY
CETIRIZINE HCl CAPSULES 10 mg / ANTIHISTAMINE

•    Indoor & outdoor allergies

25 LIQUID GELS**                                 
(**
LIQUID-FILLED CAPSULES)                
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

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

ORIGINAL
PRESCRIPTION STRENGTH
walgreens
Compare to the active ingredient in
Zyrtec®††
NDC 0363-0068-53

Allergy Relief
24 HOUR ALLERGY
CETIRIZINE HCl CAPSULES 10 mg / ANTIHISTAMINE

24 HOUR LIQUID GELS
INDOOR & OUTDOOR ALLERGIES

          •  24-hour relief of sneezing;

                runny nose; itchy, watery eyes
                & itchy throat or nose

24                                                CZ10
HOUR                                 ACTUAL SIZE

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:0363-0068
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:0363-0068-531 in 1 CARTON06/08/2020
125 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0068-121 in 1 CARTON06/08/2020
240 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20910706/08/2020
Labeler - WALGREEN CO. (008965063)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(0363-0068) , MANUFACTURE(0363-0068)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0363-0068) , MANUFACTURE(0363-0068)

Revised: 9/2021
Document Id: c74eb2ab-0bc7-475d-80dc-a569b2aaa3b8
Set id: 3d2eac7f-db44-4771-8c7e-a38e68a7f24b
Version: 4
Effective Time: 20210903
 
WALGREEN CO.