CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Apotex Corp.

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Cetrizine HCL Tablet 10 mg

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

  • 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.

Directions

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask 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, OntarioWeston, Florida
Canada M9L 1T933326

PRINCIPAL DISPLAY PANEL - 5 mg

APOTEX CORP. NDC 60505-2632-1

Cetirizine 5 mg 

Cetirizine Hydrochloride Tablets 

Antihistamine/Original Prescription Strength  

Indoor & Outdoor Allergies

24 hour  Relief of

  • Sneezing 
  • Runny Nose 
  • Itchy, Watery Eyes 
  • Itchy Throat or Nose

    100 count 

    5mg-100btl

PRINCIPAL DISPLAY PANEL - 10 mg

APOTEX CORP. NDC 60505-2633-1

Cetirizine 10 mg

Cetirizine Hydrochloride Tablets

Antihistamine/Original Prescription Strength 

Indoor & Outdoor Allergies

24 hour

Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

100 count

10mg-100btl

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-2632
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 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) Size7mm
FlavorImprint Code 5MG;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-2632-330 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
2NDC:60505-2632-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
3NDC:60505-2632-81000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/200704/30/2021
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:60505-2633-330 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
2NDC:60505-2633-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
3NDC:60505-2633-81000 in 1 BOTTLE; Type 0: Not a Combination Product12/27/200704/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/200704/30/2021
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.209429182analysis(60505-2633, 60505-2632) , manufacture(60505-2633, 60505-2632)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.205576023analysis(60505-2633, 60505-2632) , manufacture(60505-2633, 60505-2632)

Revised: 6/2019
 
Apotex Corp.