CETIRIZINE HYDROCHLORIDE tablet, film coated

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

30 Tablets

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

45 Tablets

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

90 Tablets

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

100 Tablets

Principal Display Panel

Cetirizine HCl Tablets, 10 mg

100 Tablets

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5852(NDC:60505-2633)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	RECTANGLE (pillow-shaped)	Size	9mm
Flavor		Imprint Code	10MG;APO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5852-41	14 in 1 CARTON	12/27/2007	02/29/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0904-5852-43	45 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
3	NDC: 0904-5852-46	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
4	NDC: 0904-5852-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
5	NDC: 0904-5852-89	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
6	NDC: 0904-5852-61	100 in 1 CARTON	12/27/2007	02/29/2020
6		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078317	12/27/2007

Labeler - Major Pharmaceuticals (191427277)