CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet
Preferred Pharmaceuticals, Inc

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Active Ingredients

Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine

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

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

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 Poison Control Center right away.

Directions

Adults and children 6 years and over	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 sever 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° to 25°C (68° to 77°F)

Inactive Ingredients

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Questions?

Call 1-866-562-4597

Manufactured for PACK Pharmaceuticals, LLC
Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Cetirizine Hydrochloride Tablets 10 mg Container Label

NDC 16571-402-10

Original Prescription Strength

Cetirizine Hydrochloride

Tablets 10 mg

Antihistamine 24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 Tablets

Allergy

Indoor & Outdoor

Allergies

PACK PHARMACEUTICALS LLC

Repackaged By:

Preferred Pharmaceuticals, Inc Anaheim, CA 92807

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-0790(NDC:16571-402)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetirizine Hydrochloride (Cetirizine)	Cetirizine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
hypromelloses
lactose
magnesium stearate
starch, corn
polyethylene glycol
povidone
titanium dioxide

Product Characteristics
Color	white (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

Packaging
#	Item Code	Package Description
1	NDC:68788-0790-3	30 in 1 BOTTLE
2	NDC:68788-0790-6	60 in 1 BOTTLE
3	NDC:68788-0790-9	90 in 1 BOTTLE
4	NDC:68788-0790-0	100 in 1 BOTTLE
5	NDC:68788-0790-1	14 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077829	10/01/2009

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc		791119022	repack

Revised: 04/2011

Document Id: a998f305-5180-46e8-8dbe-60b77ed3a3ef

Set id: 3fc53b32-704b-4586-aa8c-26a2a71a155a

Version: 1

Effective Time: 20110415

Preferred Pharmaceuticals, Inc