Cetirizine Hydrochloride Tablets, 5 mg, Allergy

CETIRIZINE HYDROCHLORIDE  - cetirizine hydrochloride tablet 
Pack Pharmaceuticals LLC


Cetirizine Hydrochloride Tablets, 5 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                        Purpose
Cetirizine HCl 5 mg.....................................................................................Antihistimine


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 over1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk 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 TypeHUMAN OTC DRUGNDC Product Code (Source)16571-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
magnesium stearate 
starch, corn 
polyethylene glycol 
titanium dioxide 
Product Characteristics
Colorwhite (White) Score no score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
#NDCPackage DescriptionMultilevel Packaging
116571-401-10100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date

Labeler - Pack Pharmaceuticals LLC (614823875)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Unique Pharmaceutical Laboratories650434645MANUFACTURE, analysis
Revised: 12/2009Pack Pharmaceuticals LLC