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  5. Label Information: Childrens Allergy Relief

FDA Label for Childrens Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    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. PRINCIPAL DISPLAY PANEL

Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Camber Consumer Care 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.

Active Ingredient(S)



(in each 5 mL)
Cetirizine Hydrochloride USP 5mg



Purpose



Antihistamine


Use(S)



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
    		5 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 over
    		5 mL once daily; do not take more than 5 mL in                  24 hours.
    children 2 to under 6 years of age
    		2.5 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 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 bottle wrap imprinted “SAFETY SEAL®” is broken or missing
  • see top panel for lot number and expiration date

Inactive Ingredients



anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.


Questions?



call 1-888-588-1418
                                              
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.

Mfg. Lic. No.: 22/RR/AP/2001/F/R




Principal Display Panel



Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label



cetirizinehcloscontlabel - cetirizinehcloscontlabel

cetirizinehcloscontlabel - cetirizinehcloscontlabel




Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label






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