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  5. Label Information: Childrens Cetirizine Hydrochloride Allergy

FDA Label for Childrens Cetirizine Hydrochloride Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING:
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 MG/ML (120 ML BOTTLE)
    16. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 MG/ML CARTON (120 ML)

Childrens Cetirizine Hydrochloride Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. 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.

Active Ingredient (In Each 5 Ml)




Cetirizine hydrochloride USP 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

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.


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.

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.

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 only with enclosed dosing cup
  • find right dose on chart below
  • mL = Milliliter

    • adults and children 6 years and over
    		  1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
    adults 65 years and over
    		  1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age
    		  ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
    children under 2 years of age
    		  ask a doctor
    consumers with liver or kidney disease   
    		  ask a doctor

Other Information



  • store between 20° to 25°C (68° to 77°F)
  • Do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive Ingredients




cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose


Questions?




call 1-855-274-4122

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if cap safety seal is broken or missing.

Manufactured for:
AUROHEALTH LLC,
 2572 Brunswick Pike,
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R


Package Label-Principal Display Panel - 1 Mg/Ml (120 Ml Bottle)




AUROHEALTH

NDC 58602-028-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

Package Label-Principal Display Panel - 1 Mg/Ml Carton (120 Ml)





AUROHEALTH

NDC 58602-028-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine                  ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

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