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  5. Label Information: Alleroff

FDA Label for Alleroff

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - ASK DOCTOR
    3. OTC - ASK DOCTOR/PHARMACIST
    4. OTC - DO NOT USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - STOP USE
    8. OTC - PURPOSE
    9. OTC - QUESTIONS
    10. STORAGE AND HANDLING
    11. DOSAGE & ADMINISTRATION
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alleroff Product Label

The following document was submitted to the FDA by the labeler of this product Corporacion Infarmasa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



(in each 5 ml teaspoonful) Cetirizine HCL 5 mg..........Antihistamine

Otc - Ask Doctor



Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a differentdose.

Otc - Ask Doctor/Pharmacist




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

Otc - Do Not Use



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


Otc - Keep Out Of Reach Of Children




In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)



Otc - Pregnancy Or Breast Feeding




If pregnant or breast feeding:

  • if breast feeding: not recommended
  • if pregnant: ask a health professional before use

Otc - Stop Use



Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.


Otc - Purpose




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

Otc - Questions



If you have questions of a medical nature, please contact your pharmacist, doctor or health care profesional

Questions or comments? 561 338 5221


Storage And Handling




Store between 20°C to 25°C ( 68°F to 77°F)

See bottom panel for lot number and expiration date


Dosage & Administration



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


Inactive Ingredient



Citric and monohydrate, Sodium Benzoate, Sodium Citrate Tribasic Dihydrate, FDC Red N° 40, Disodium Edetate, Strawberry Essence Liquid, Glycerol, Saccharin Sodium, Sorbitol, Purified Water


Package Label.Principal Display Panel



Image of Carton Label - ALLEROFF jar

Image of Carton Label - ALLEROFF jar

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* Please review the disclaimer below.