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  5. Label Information: Fexofenadine Hydrochloride

FDA Label for Fexofenadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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 USP, 180 mg


Purpose




Antihistamine


Uses




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

  • runny nose
  • runny nose
  • itchy, watery 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 aluminium or magnesium antacids
  • do not take with fruit juices (see directions)

Stop Use And Ask 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






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 and light

Inactive Ingredients





anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,


Questions Or Comments?




 call 1-855-274-4122


Principal Display Panel





NDC 46122-387-23
 
Original Prescription Strength
Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy
Indoor & Outdoor Allergies


Relief of:                24 Hour

 Sneezing 
 Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

5 Tablets 180 mg each



Blister- pack-180mg-5s-count - fexofenadine fig 1

Blister- pack-180mg-5s-count - fexofenadine fig 1




 


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