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


Drug Facts

ALLEROFF  - cetirizine hydrochloride syrup 
Corporacion Infarmasa

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Drug Facts


(in each 5 ml teaspoonful) Cetirizine HCL 5 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


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

See bottom panel for lot number and expiration date

Use only with enclosed dosing cup

Adults and Children 6 years and over             1 teaspoonful (5ml) ot 2 teaspoonful (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonful (10ml) in 24        hours

Adults 65 years and over                               1 teaspoonful (5ml) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours

Children 2 to under 6 years of age                   1/2 teaspoonful (2.5ml) once daily.If needed, dose can be increased to a maximum of 1 teaspoon (5ml) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours

Children under 2 years of age                          Ask a Doctor

Consumer with liver or kidney disease             Ask a Doctor

Citric and monohydrate, Sodium Benzoate, Sodium Citrate Tribasic Dihydrate, FDC Red Nº 40, Disodium Edetate, Strawberry Essence Liquid, Glycerol, Saccharin Sodium, Sorbitol, Purified Water

Image of Carton LabelEnter section text here


ALLEROFF 
cetirizine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16853-1261
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (Cetirizine) CETIRIZINE HYDROCHLORIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 0.080 mg
SODIUM BENZOATE 0.100 mg
SODIUM CITRATE 0.090 mg
FD&C RED NO. 40 0.003 mg
EDETATE DISODIUM 0.025 mg
GLYCERIN 25 mg
SACCHARIN SODIUM 0.075 mg
SORBITOL 30 mg
WATER 100 mL
STRAWBERRY 0.07 mg
Product Characteristics
Color pink (pink) Score     
Shape Size
Flavor STRAWBERRY (Strawberry) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16853-1261-1 1 SYRUP ( BOTTLE) in 1 CARTON None
2 NDC:16853-1261-2 2 SYRUP ( BOTTLE) in 1 PACKAGE, COMBINATION None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022155 01/15/2010

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

Revised: 01/2010 Corporacion Infarmasa



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


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