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  5. Label Information: Dye Free Childrens Cetirizine Hydrocholride

FDA Label for Dye Free Childrens Cetirizine Hydrocholride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. IF PREGNANT OR BREAST-FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. HOW SUPPLIED
    16. PRINCIPAL DISPLAY PANEL - 5 ML CUP LABEL

Dye Free Childrens Cetirizine Hydrocholride Product Label

The following document was submitted to the FDA by the labeler of this product Precision Dose, Inc.. 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.

Other



Grape Flavor

5 mg/5 mL

For Hospital Use Only

Drug Facts

Dye Free, Gluten Free, Sugar Free

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI1060 Rev. 05/16


Active Ingredient (In Each 5 Ml)



Cetirizine HCl 5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings



Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


Otc - Ask Doctor



Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


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 - Stop Use



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


If Pregnant Or Breast-Feeding



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

Otc - Keep Out Of Reach Of Children



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)


Directions



  • Use as directed per healthcare professional.
  • mL = milliliter
    • adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
    adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • store between 20° to 25°C (68° to 77°F)
  • See individual label or shipper for lot number and expiration date.

Inactive Ingredients



anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose


How Supplied



NDC 68094-004-62
5 mL per unit dose cup
Thirty (30) cups per shipper


Principal Display Panel - 5 Ml Cup Label



NDC 68094-004-59
PrecisionDose ™

Children's CETIRIZINE HCl
Oral Solution
5 mg/5 mL
DYE
FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - dye 01

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label - dye 01


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