CETIRIZINE HYDROCHLORIDE  - cetirizine hydrochloride tablet 
Pack Pharmaceuticals LLC


Cetirizine Hydrochloride Tablets, 5 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose


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


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.


Adults and children 6
 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
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.


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 5 mg Container Label

NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride

Tablets 5 mg

Antihistamine 24 Hour Relief of:

100 Tablets


Indoor & Outdoor



Container Label

cetirizine hydrochloride   tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 16571-401
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
magnesium stearate  
starch, corn  
polyethylene glycol  
titanium dioxide  
Product Characteristics
Color white (White) Score no score
Shape BULLET (Barrel Shaped) Size 7mm
Flavor Imprint Code CTN;5
# NDC Package Description Multilevel Packaging
1 16571-401-10 100 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)
Name Address ID/FEI Operations
Unique Pharmaceutical Laboratories 650434645 MANUFACTURE, analysis
Revised: 12/2009 Pack Pharmaceuticals LLC