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  5. Label Information: Children Allergy Relief Dye Free Cherry

FDA Label for Children Allergy Relief Dye Free Cherry

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH 5 ML)
    2. PURPOSE
    3. USES
    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 INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Children Allergy Relief Dye Free Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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)



Diphenhydramine HCl 12.5 mg


Purpose



Antihistamine


Uses



  • 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 chronic bronchitis


Ask A Doctor Or Pharmacist Before Use If The Child Is



taking sedatives or tranquilizers


When Using This Product



  • 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

(1-800-222-1222).


Directions



  • find right dose on chart below
    • mL=milliliter
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

      • AGE(yr) DOSE(mL)
      children under  2 years  do not use
      children 2 to 5 years do not use unless directed by a doctor
      children 6 to 11 years 5 mL to 10 mL

Other Information



  • each 5 mL contains: sodium 5 mg
  • dosing cup provided 
  • store between 20 - 25oC (68o- 77oF)

Inactive Ingredients



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


Questions Or Comments?



Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST


Principal Display Panel



SUNMARK®

COMPARE TO CHILDREN'S BENADRYL®

ORAL SOLUTION ACTIVE INGREDIENT*

NDC 70677-0144-1


children's allergy relief dye-free


Relieves: Sneezing,

Runny Nose,

Itchy, Watery Eyes

& Itching of the Nose or Throat


4-6 Hours/Dose

ANTIHISTAMINE

DIPHENHYDRAMINE HCl 12.5 MG/5 mL ORAL SOLUTION

CHERRY FLAVOR


4 FL OZ(118 mL)

549-4 - 549 4 fl oz

549-4 - 549 4 fl oz




* Please review the disclaimer below.