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ALLEROFF by Corporacion Infarmasa

Dosage form: syrup
Ingredients: CETIRIZINE HYDROCHLORIDE 1mg
Labeler: Corporacion Infarmasa
NDC Code: 16853-1261

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

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ALLEROFF 
cetirizine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1261
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (Cetirizine) CETIRIZINE HYDROCHLORIDE1 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE0.080 mg
SODIUM BENZOATE0.100 mg
SODIUM CITRATE 0.090 mg
FD&C RED NO. 400.003 mg
EDETATE DISODIUM0.025 mg
GLYCERIN25 mg
SACCHARIN SODIUM0.075 mg
SORBITOL30 mg
WATER100 mL
STRAWBERRY0.07 mg
Product Characteristics
Colorpink (pink) Score    
ShapeSize
FlavorSTRAWBERRY (Strawberry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16853-1261-11 SYRUP (BOTTLE) in 1 CARTON
2NDC:16853-1261-22 SYRUP (BOTTLE) in 1 PACKAGE, COMBINATION
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02215501/15/2010
Labeler - Corporacion Infarmasa (934098294)
Establishment
NameAddressID/FEIOperations
Corporacion Infarmasa934098294manufacture

Revised: 01/2010
 
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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