FDA Label for Childrens Allegra Allergy

View Indications, Usage & Precautions

Childrens Allegra Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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)

Fexofenadine HCI 30 mg


Purpose



Antihistamine


Uses



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

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

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients.


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)

Stop Use And Ask A Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


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.


Directions



  • place 1 tablet on tongue; tablet disintegrates, with or without water
  • adults and children 12 years of age and overtake 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of agetake 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
    children under 6 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

Other Information



  • each tablet contains: sodium 5 mg
  • phenylketonurics: contains phenylalanine 5.3 mg per tablet
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° and 25°C (68° and 77°F)
  • use tablet immediately after opening individual blister

Inactive Ingredients



aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate


Questions Or Comments?



call toll-free 1-800-633-1610 or www.allegra.com 

Dist. By: Chattem, Inc.(part of the sanofi-aventis Group),

Chattanooga, TN 37409-0219 ©2010             50094020


Principal Display Panel



NDC 41167-4232-1
NON-DROWSY

Children’s

Allegra
® 
Allergy

fexofenadine
HCl orally disintegrating
tablet 30
mg/antihistamine
Indoor and Outdoor Allergies

Orange Cream flavored

12 Orally Disintegrating Tablets


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