1. Home
  2. Labeler Index
  3. Cardinal Health 110, Llc. Dba Leader
  4. 70000-0693
  5. Label Information: Childrens Allergy Relief Dye Free

FDA Label for Childrens Allergy Relief Dye Free

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    8. WHEN USING THIS PRODUCT
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGRADIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Childrens Allergy Relief Dye Free 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(S)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


Use(S)



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies :
  • runny nose
  • itchy, watery eyes 
  • sneezing 
  • itching of the nose or throat 

Warnings



.


Do Not Use



  • to make a child sleepy 
  • with any other product containing diphenhydramine, even one used  on skin

Ask A Doctor Before Use If The Child Has



  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium restricted diet 

Ask A Doctor Or Pharmacist Before Use If The Child Is



taking sedatives or tranquilizers.


When Using This Product



  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • marked drowsiness may occur
  • excitability may occur especially in children 

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours 
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device


    • AGE(yr)DOSE(mL or tsp) 
     children under 2 years  do not use
     children 2 to under 6 years  ask a doctor
     children 6 to under 12 years  1 to 2 tsp (5 mL to 10 mL)

Other Information



  • each tsp contains: sodium 5 mg 
  • store at 68o -77o F

Inactive Ingradients



carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.


Questions Or Comments?



(609) 860-2600


Principal Display Panel



LEADER TM

NDC 70000-0693-1

DYE-FREE

Children's Allergy Relief 

Diphenhydramine HCl

12.5mg /5 mL Oral Solution 

Antihistamine

Cherry

Flavored Liquid

4-6 hours/Dose

Relief of:

Sneezing 

Runny Nose 

itchy, water eyes

itchy Throat

or Nose

Alcohol -Free

100% Money Back Guarantee

8 FL OZ (236 mL)

549-lbl.jpg - 549 lbl

549-lbl.jpg - 549 lbl


* Please review the disclaimer below.