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  5. Label Information: Kids-eeze Allergy

FDA Label for Kids-eeze Allergy

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFT CHEW)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 12.5 MG PACKAGE

Kids-eeze Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Prophase Labs, 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.

Other



Drug Facts


Active Ingredient (In Each Soft Chew)



Diphenhydramine Hydrochloride 12.5mg


Purpose



Antihistamine


Uses



For the temporary relief of

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies

Do Not Use



  • with any other product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have



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

Otc - Ask Doctor/Pharmacist



Ask a doctor before use if you are taking sedatives or tranquilizers.


When Using This Product



  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



Chew and swallow as directed below

  • Do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2 to 4 chews every 4 to 6 hours
    children 6 years to under 12 years1 to 2 chews every 4 to 6 hours
    children under 6 years of ageask a doctor

Other Information



  • each soft chew contains 6 mg sodium
  • tamper evident: do not use if inner blister pack is torn or open
  • store at controlled room temperature 15-30°C (59-86°F)

Inactive Ingredients



ammonium glycyrrhizinate, cellulose, croscarmellose sodium, D&C red #27 lake, ethylcellulose, FD&C blue #1 lake, fructose, flavors, hydroxypropylcellulose, lecithin, malic acid, microcrystalline cellulose, sodium chloride, sucralose, sugar, vegetable oil, xylitol


Otc - Questions



To report serious side effects associated with the use of this product call 1-800-505-COLD (2653)


Principal Display Panel - 12.5 Mg Package



NDC 61941-1005-6

Kids-EEZE®
From The Makers Of
Cold-EEZE®

Allergy

ANTIHISTAMINE • DIPHENHYDRAMINE HCl 12.5mg
Due to hay fever or upper respiratory allergies

For relief of:

* Please review the disclaimer below.