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  5. Label Information: Childrens Allergy

FDA Label for Childrens Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU ARE TAKING SEDATIVES OR TRANQUILIZERS
    8. WHEN USING THIS PRODUCT
    9. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Childrens Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Capricorn Pharma 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 Tablet)



Diphenhydramine HCl 12.5mg


Purpose



Antihistamine


Indications & Usage



Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.


Warnings





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



  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of prostate gland

Ask A Doctor Before Use If You Are Taking Sedatives Or Tranquilizers





When Using This Product



  • Avoid alcoholic beverages
  • Marked drowsiness may occur
  • Alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Excitability may occur, especially in children
  • Be careful when driving a motor vehicle or operating machinery



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 Center right away (1-800-222-1222).


Directions



  • Take every 4 to 6 hours
  • Do not take more than 6 times in 24 hours
    • Adults and Children 12 years of age and over2 to 4 tablets
    Children 6 to under 12 years of age1 to 2 tablets
    Children under 6 years of ageConsult a doctor
    Children under 4 years of ageDo not use

Other Information



  • Do not use if carton is opened or blister unit is broken
  • Store between 20-25°C (68-77°F).  Avoid high humidity. Protect from light.
  •  See end panel for lot number and expiration date.

Inactive Ingredients



aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose,  modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin


Principal Display Panel



Capricorn Pharma

ORIGINAL DEVELOPERS AND MANUFACTURERS

NDC 66007-212-02

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT

Children's Allergy

Diphenhydramine HCl 12.5mg

ANTIHISTAMINE

Temporarily Relieves:

* Please review the disclaimer below.