Cetirizine Hydrochloride Tablets, 10 mg, Allergy

CETIRIZINE HYDROCHLORIDE  - cetirizine hydrochloride tablet 
Pack Pharmaceuticals LLC

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Cetirizine Hydrochloride Tablets, 10 mg, Allergy

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

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 TypeHUMAN OTC DRUGNDC Product Code (Source)16571-402
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose 
lactose 
magnesium stearate 
starch, corn 
polyethylene glycol 
povidone 
titanium dioxide 
Product Characteristics
Colorwhite (White) Score no score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
116571-402-10100 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009

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