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  5. Label Information: Health Mart Childrens Allergy Relief

FDA Label for Health Mart Childrens Allergy Relief

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 THE CHILD HAS
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    7. WHEN USING THIS PRODUCT
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Health Mart Childrens Allergy Relief 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:
  • •sneezing
  • •itching of the nose or throat
  • •runny nose
  • •itchy, watery eyes

Do Not Use



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

Ask A Doctor Before Use If The Child Has



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

Ask A Doctor Or Pharmacist Before Use If The Child Is



taking sedatives or tranquilizers


When Using This Product



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

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
  • •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

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • •each 5 mL contains: sodium 15 mg
  • •store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution


Questions Or Comments?



1-800-719-9260


Principal Display Panel



compare to Children’s Benadryl® active ingredient

children’s allergy relief

diphenhydramine HCl 12.5 mg/5 mL oral solution

antihistamine

relieves:

sneezing

runny nose

itchy throat

itchy, watery eyes

4-6 hours/dose

alcohol free

gluten free

cherry flavored

4 fl oz (118 mL)


* Please review the disclaimer below.