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CETIRIZINE HYDROCHLORIDE by Apotex Corp.

Medically reviewed on February 6, 2018

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Apotex Corp.
NDC Code: 60505-4650

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 10

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 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. (1-800-222-1222)

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)
  • do not use if seal under bottle cap is broken or missing
  • meets USP Dissolution Test 3

Inactive ingredients

carnauba wax, hypromellose, lactose monohydrate, magnesiumstearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch (corn) and titanium dioxide.

Questions or comments? 

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

Principal Display Panel

Just Well NDC 60505-4650-6

Original Prescription Strength

allergy relief

Cetirizine HCl Tablets, USP 10 mg 

Antihistamine

Indoor & Outdoor Allergies 

24 hour  Relief of:

Sneezing 

Runny Nose 

Itchy, Watery Eyes 

Itchy Throat or Nose 

365 count Bottle

Principal Display Panel

Just Well NDC 60505-4650-6

Original Prescription Strength

allergy relief

Cetirizine HCl Tablets, USP 10 mg 

Antihistamine

Indoor & Outdoor Allergies 

24 hour  Relief of:

Sneezing 

Runny Nose 

Itchy, Watery Eyes 

Itchy Throat or Nose 

365 count Carton

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4650
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
STARCH, CORN 
TITANIUM DIOXIDE 
CARNAUBA WAX 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-4650-61 BOTTLE in 1 CARTON
1365 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831702/06/2018
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4651
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
STARCH, CORN 
TITANIUM DIOXIDE 
CARNAUBA WAX 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-4651-61 BOTTLE in 1 CARTON
165 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831702/06/201802/22/2018
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Apotex Inc.209429182manufacture(60505-4650, 60505-4651), analysis(60505-4650, 60505-4651)

 
Apotex Corp.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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