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  5. Label Information: Childrens Allergy

FDA Label for Childrens Allergy

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE CARTON

Childrens Allergy Product Label

The following document was submitted to the FDA by the labeler of this product H2-pharma, 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.

Other



Drug Facts

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117


Active Ingredient (In Each 5 Ml)



Fexofenadine HCl, USP 30 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Otc - Do Not Use



Do not use if you have ever had an allergic reaction to this product or any of its ingredients.


Otc - Ask Doctor



Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.


When Using This Product



  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Otc - Stop Use



Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.


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


Directions



  • shake well before using
  • use only with enclosed dosing cup
    • Note: mL = milliliters
    adults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
    children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
    children under 2 years of ageask a doctor
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

Other Information



  • each 5 mL contains: sodium 18 mg
  • store between 20° to 25°C (68° to 77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients



artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol


Questions Or Comments?



Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


Principal Display Panel - 237 Ml Bottle Carton



NDC 61269-527-98

*Compare to the active ingredient
in Children's Allegra® Allergy

Children's
Allergy

Fexofenadine HCl
Oral Suspension 30 mg/5 mL

Antihistamine

Indoor/Outdoor allergy relief
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

12 Hour Relief
Ages 2 years and older
Non-drowsy
Dye-free
Alcohol-free

Use only with
enclosed dosing cup.
Wash and let air dry
after each use.

BERRY FLAVOR

8 fl oz (237 mL)

H2 pharma

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton - childrens allergy 01

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton - childrens allergy 01


* Please review the disclaimer below.