CETIRIZINE HYDROCHLORIDE  - cetirizine hydrochloride tablet 
Pack Pharmaceuticals LLC

----------

Cetirizine Hydrochloride Tablets, 10 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

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 Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

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

100 Tablets

Allergy

Indoor & Outdoor

Allergies

PACK PHARMACEUTICALS LLC

Container Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 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
hypromellose  
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
# NDC Package Description Multilevel Packaging
1 16571-402-10 100 TABLET In 1 BOTTLE None

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

Labeler - Pack Pharmaceuticals LLC (614823875)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
Name Address ID/FEI Operations
Unique Pharmaceutical Laboratories 650434645 MANUFACTURE, analysis
Revised: 12/2009 Pack Pharmaceuticals LLC