FDA Label for Allegra Allergy

View Indications, Usage & Precautions

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 HCl 60 mg

(in each tablet)

Fexofenadine HCl 180 mg

(in each tablet)

Fexofenadine HCl 180 mg


Purpose



Antihistamine

Antihistamine

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
  • 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
    • 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

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

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.

kidney disease. Your doctor should determine if you need a different dose.

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)
    • 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)
      • 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.

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

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


If Pregnant Or Breast-Feeding,



ask a health professional before use.

ask a health professional before use.

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.

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

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


Directions



 adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take
more than 2 tablets in 24 hours
 children under 12 years of agedo not use
 adults 65 years of age and olderask a doctor
 consumers with kidney diseaseask a doctor
 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take
more than 1 tablet in 24 hours
 children under 12 years of agedo not use
 adults 65 years of age and olderask a doctor
 consumers with kidney diseaseask a doctor
 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take
more than 1 tablet in 24 hours
 children under 12 years of agedo not use
 adults 65 years of age and olderask a doctor
 consumers with kidney diseaseask a doctor

Other Information



  • 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)
  • protect from excessive moisture
    • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
      • 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)
      • protect from excessive moisture

Inactive Ingredients



colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

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


Questions Or Comments?



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



Allegra Allergy® - 24 HOUR

Drug Facts

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


Allegra Allergy® - 24 HOUR

Drug Facts


Principal Display Panel



NDC 41167-4120-2
Allegra® Allergy
fexofenadine HCl tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
15 Tablets
24 HOUR

NDC 41167-4120-3
Allegra® 
Allergy
fexofenadine HCl tablet
180 mg/antihistamine 24 HOUR
Indoor and Outdoor Allergies
30 Tablets

NDC 41167-4131-2
Allegra® Allergy
fexofenadine HCl tablet 60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets
12 HOUR


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