CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Cardinal Health

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Cetrizine HCL Tablet 10 mg

Cetirizine Hydrochloride Tablets, USP 10 mg
Antihistamine/Original Prescription Strength
Indoor and Outdoor Allergies
Relief of: Sneezing; Runny Nose
Itchy,Watery Eyes
Itchy Throat or Nose
APOTEX
24 Hour Allergy

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 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

1.
drowsiness may occur
2.
avoid alcoholic drinks
3.
alcohol, sedatives, and tranquilizers may increase drowsiness
4.
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 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

•
store between 20° and 25°C (68° - 77°F)
•
USP Dissolution Test 3

Inactive ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions or comments?

call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:

Manufactured for:

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, Florida

Canada M9L 1T9

Repackaged by:

Cardinal Health

Zanesville, OH 43701

IH50551650115

33326

Principal Display Panel

Cetirizine (cetirizine hydrochloride)

Tablet, USP

10 mg

lidding label

Principal Display Panel

Cetirizine

(cetirizine hydrochloride)

Tablets, USP

10 mg

100 Tablets (10 x 10)

carton label

Principal Display Panel

Cetirizine (cetirizine hydrochloride)

Tablet, USP

10 mg

100 Tablets (10 x 10)

carton
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6675(NDC:60505-2633)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code 10MG;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6675-4100 in 1 CARTON12/27/200705/31/2017
1NDC:55154-6675-71 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/200705/31/2017
Labeler - Cardinal Health (188557102)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6675)

Revised: 1/2018
Document Id: ab502ff4-a410-4fc3-bf92-10a0e2dfc82b
Set id: 2eda9bc4-211c-4a4b-b30c-8f28fea3113b
Version: 2
Effective Time: 20180122
 
Cardinal Health