FDA Label for Leader Childrens All Day Allergy

View Indications, Usage & Precautions

Leader Childrens All Day Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 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

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 if printed neckband is broken or missing
  • •see bottom panel for lot number and expiration date

Inactive Ingredients



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


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Children’s

All Day Allergy

Cetirizine Hydrochloride

Oral Solution 1mg/mL

Antihistamine

Indoor & Outdoor Allergies

Grape Flavor

Ages 2 Years and Older

24-Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Dye-Free

Sugar-Free

COMPARE TO CHILDREN’S ZYRTEC®

active ingredient

100% Money Back Guarantee

4 FL OZ (118mL)


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