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  5. Label Information: Childrens Allergy

FDA Label for Childrens Allergy

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU
    7. WHEN USING THIS PRODUCT
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Childrens Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. 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.

Drug Facts



Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 12.5 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

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 You



are 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



  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter 

    • Age (yr)
    		Dose (mL)
    children under 6 years of age
    		ask a doctor
    children 6 years to under 12 years of age
    		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 9 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive Ingredients



anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179


Package Label-Principal Display Panel



NDC 17856-0361-01

Compare to
Children's Benadryl®
active ingredient*

Children's
ALLERGY
Antihistamine
diphenhydramine hydrochloride
25mg/10 mL oral solution 
liquid medication

Relieves:

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

    • Sugar & Alcohol Free
    Dye-FreeBubble Gum Flavored


    image 1 - 17856 0361 01

    image 1 - 17856 0361 01



    NDC 17856-0361-02

    Compare to
    Children's Benadryl®
    active ingredient*

    Children's
    ALLERGY

    Antihistamine

    diphenhydramine hydrochloride
    12.5mg/5mL oral solution
    liquid medication

    Relieves:

    Runny Nose
    Sneezing
    Itchy, Watery Eyes
    Itchy Throat
    Sugar & Alcohol Free

    Dye-Free
    Bubble Gum Flavored



* Please review the disclaimer below.