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Name:Alleroff
Manufacturer:Corporacion Infarmasa
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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:

  • Drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

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:

  • if breast feeding: not recommended
  • if pregnant: ask a health professional before use

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:

  • Runny Nose
  • Itchy,water eyes
  • Itching of the nose or throat
  • Sneezing

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 Type HUMAN OTC DRUG Item Code (Source) NDC:16853-1307
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (Cetirizine) CETIRIZINE HYDROCHLORIDE 10.0 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 150.0 mg
CROSCARMELLOSE SODIUM 5.0 mg
LACTOSE MONOHYDRATE 50.0 mg
MAGNESIUM STEARATE 2.0 mg
Product Characteristics
Color white (white) Score score with uneven pieces
Shape ROUND (Tablet) Size 8mm
Flavor Imprint Code None
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16853-1307-2 00000000000003 BLISTER PACK ( BLISTER PACK) in 1 BOX contains a BLISTER PACK (16853-1307-1)
1 NDC:16853-1307-1 000000000010 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the BOX (16853-1307-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019835 01/01/2010

Labeler - Corporacion Infarmasa (934098294)
Establishment
Name Address ID/FEI Operations
Corporacion Infarmasa 934098294 manufacture

Revised: 02/2010 Corporacion Infarmasa



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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