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Corporacion Infarmasa

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient










  • 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 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.

Purpose






  • 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


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ALLEROFF

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label 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 10.0 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white (white) 8 mm None ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16853-1307-1 000000000010 in 1 BLISTER PACK
2 NDC:16853-1307-2 00000000000003 in 1 BOX

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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