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  5. Label Information: Childrens Fexofenadine Hydrochloride Allergy

FDA Label for Childrens Fexofenadine Hydrochloride 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?
    15. PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON

Childrens Fexofenadine Hydrochloride Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., 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

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532


Active Ingredient (In Each 5 Ml)



Fexofenadine HCl 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 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 14 mg
  • safety sealed: do not use if carton is opened, or if imprinted safety seal is broken or missing.
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients



artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum


Questions?



Call 1-866-923-4914


Principal Display Panel - 120 Ml Bottle Carton



NDC 51672-2141-8

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

Children's
Allergy
Fexofenadine HCl
Oral Suspension,
30 mg/ 5 mL
Antihistamine

NON-DROWSY

12
Hour

Berry Flavor

2
Years
& Older

INDOOR/OUTDOOR
ALLERGY RELIEF

* Please review the disclaimer below.