CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated 
Major Pharmaceuticals

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Cetrizine HCL Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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 over

 Take 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)

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:

Apotex In c.

Toronto, Ontario

Canada M9L 1T9

Manufactured for:

Apotex Corp.

Weston, Florida

33326

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Principal Display Panel

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

Cetirizine HCl Tablets, 10 mg

14 Tablets

carton

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

30 Tablets

bottle label

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

45 Tablets

bottle label

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

90 Tablets

bottle label

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

100 Tablets

bottle label

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

100 Tablets

carton label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5852(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:0904-5852-4114 in 1 CARTON12/27/200702/29/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0904-5852-4345 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
3NDC:0904-5852-4630 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
4NDC:0904-5852-60100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
5NDC:0904-5852-8990 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
6NDC:0904-5852-61100 in 1 CARTON12/27/200702/29/2020
61 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/2007
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2019
Document Id: 6d815389-b3c5-4e07-a2d1-56a3a24dc5fe
Set id: 93426a9b-e33a-40f7-8b38-7390a14d77da
Version: 8
Effective Time: 20191212
 
Major Pharmaceuticals