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  5. Label Information: Allergy Childrens

FDA Label for Allergy Childrens

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 YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Allergy Childrens Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributors Inc.. 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

*5 mL = 1 teaspoon (tsp)


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
  • temporarily relieves these symptoms due to common cold:
  • runny nose
  • sneezing

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 You Have



  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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



  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives or tranquilizers may increase drowsiness
  • be careful when operating a motor vehicle or operating machinery
  • excitability may occur especially in children

If Pregnant Or Breast-Feeding



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



  • take every 4 - 6 hours
  • do not take more than 6 times in 24 hours

    • Age (yr)

    Dose

    Adult and children 12

    years of age and over

    10-20 mL

    (25 to 50 mg)

    Children 6 to under

    12 years of age

    5-10 mL

    (12.5 to 25 mg)

    Children under 6 years

    of age

    Ask a doctor


Other Information



  • store at room temperature 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 16 mg

Inactive Ingredients



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, sodium sacchrin, sorbitol, sucrose


Questions Or Comments?



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel



Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

See New Warnings and Directions

CHILDREN'S ALLERGY

LIQUID MEDICATION

DIPHENHYDRAMINE HCl

ORAL SOLUTION

ANTIHISTAMINE

Relieves: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

Cherry Flavored

Alcohol Free


* Please review the disclaimer below.