ALLEROFF  - cetirizine hydrochloride tablet 
Corporacion Infarmasa

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Drug Facts


Cetirizine HCL 10 mg..........Antihistamine


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:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hidroxyzine


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)



If pregnant or breast feeding:

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


Uses

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

If you have questions of a medical nature, please contact your pharmacist, doctor or health care profesional

Questions or comments? 561 338 5221

Do not use if blister unit is broken or lorn

Store between 20ºC to 25ºC ( 68ºF to 77ºF)

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 strenght may be appropiate for less severe symptoms

Adults 65 years and over                               Ask a Doctor

Children under 6 years of age                         Ask a Doctor

Consumer with liver or kidney disease             Ask a Doctor

Microcrystalline Cellulose, Lactose Monohydrate, Crosscaramellose Sodium, Magnesium Stearate


Image of Carton Label


ALLEROFF 
cetirizine hydrochloride   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)16853-1307
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (Cetirizine) CETIRIZINE HYDROCHLORIDE10.0 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE150.0 mg
CROSCARMELLOSE SODIUM5.0 mg
LACTOSE MONOHYDRATE50.0 mg
MAGNESIUM STEARATE2.0 mg
Product Characteristics
Colorwhite (white) Score score with uneven pieces
ShapeROUND (Tablet) Size8mm
FlavorImprint Code None
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
116853-1307-200000000000003 BLISTER PACK In 1 BOXcontains a BLISTER PACK (16853-1307-1)
116853-1307-1000000000010 TABLET In 1 BLISTER PACKThis package is contained within the BOX (16853-1307-2)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983501/01/2010

Labeler - Corporacion Infarmasa (934098294)
Establishment
NameAddressID/FEIOperations
Corporacion Infarmasa934098294manufacture
Revised: 02/2010Corporacion Infarmasa