active ingredient

CETIRIZINE HYDROCHLORIDE

Purpose

Antihistamine

Keep out of reach of children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

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.

Warning

If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Dosage and Administration

Adults and children 6years andover 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 65years and over: ask a doctor.

Children under 4-6 years of age: ask a doctor

Children under 4 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

Inactive Ingredient

LACTOSE MONOHYDRATE

Inactive Ingredient

STARCH, CORN

Inactive Ingredient

GELATIN

Inactive Ingredient

METHYLPARABEN

Inactive Ingredient

TITANIUM DIOXIDE

Inactive Ingredient

MAGNESIUM STEARATE

Inactive Ingredient

TALC

Inactive Ingredient

SODIUM STARCH GLYCOLATE TYPE A POTATO

DISPLAY PANEL

APTRIZINE 24-HOUR ALL DAY ALLERGY
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46084-012
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)	21.66 mg
STARCH, CORN (UNII: O8232NY3SJ)	85.32 mg
GELATIN (UNII: 2G86QN327L)	2.4 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	.2 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	.1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	1.3 mg
TALC (UNII: 7SEV7J4R1U)	3.9 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	3.9 mg

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (no score)	Size	7mm
Flavor		Imprint Code	10mg
Contains

#	Item Code	Package Description
Packaging
1	NDC:46084-012-15	120 in 1 BLISTER PACK
2	NDC:46084-012-14	60 in 1 BLISTER PACK
3	NDC:46084-012-13	45 in 1 BLISTER PACK
4	NDC:46084-012-12	30 in 1 BLISTER PACK
5	NDC:46084-012-11	15 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA019835	02/21/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Name	Address	ID/FEI	Business Operations
Establishment
A P J Laboratories Limited		677378339	manufacture(46084-012)