Alleroff Drug Facts

Generic Name: cetirizine hydrochloride

Dosage Form: tablet
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

ALLEROFF  cetirizine hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 16853-1305 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 # NDC Package Description Multilevel Packaging 1 16853-1305-2 00000000000001 BLISTER PACK In 1 BOX contains a BLISTER PACK (16853-1305-1) 1 16853-1305-1 000000000010 TABLET In 1 BLISTER PACK This package is contained within the BOX (16853-1305-2) 2 16853-1305-3 0000000002 TABLET In 1 BLISTER PACK None

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: 02/2010Corporacion Infarmasa

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• Alleroff Drug Facts Support Group
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