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ALLEROFF by Corporacion Infarmasa

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10.0mg
Labeler: Corporacion Infarmasa
NDC Code: 16853-1305

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1305
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) Scorescore with uneven pieces
ShapeROUND (Tablet) Size8mm
FlavorImprint CodeNone
Contains    
Packaging
#Item CodePackage Description
1NDC:16853-1305-200000000000001 BLISTER PACK (BLISTER PACK) in 1 BOX
1NDC:16853-1305-1000000000010 TABLET (TABLET) in 1 BLISTER PACK
2NDC:16853-1305-30000000002 TABLET (TABLET) in 1 BLISTER PACK
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: 02/2010
 
Corporacion Infarmasa

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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