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  5. Label Information: Fexofenadine Hydrochloride

FDA Label for Fexofenadine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

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

Fexofenadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Laboratories Limited. 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(S)



Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg


Purpose



Antihistamine


Use(S)



Allergy

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

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

    • Hives

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction  from occuring.




Warnings



Hives

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:

  • trouble swallowing  
  • dizziness or loss of consciousness 
  • swelling of tongue  
  • swelling in or around mouth 
  • trouble speaking 
  • drooling 
  • wheezing or problems breathing  

    • These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.


Do Not Use



Allergy

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

Hives

  • to prevent hives from any known cause such as: 
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

      • because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

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

Ask A Doctor Before Use If You Have



Allergy

  • kidney disease. Your doctorshould determine if you need a different dose.

    • Hives

    • kidney disease. Your doctor should determine if you need a different dose.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

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 Doctor If



Allergy

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

Hives

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

  • symptoms do not improve after 3 days of treatment

  • the hives have lasted more than 6 weeks


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



30 mg

adults and children 12 years of age and over         take two 30 mg tablets with water every 12 hours;  do not take more than 4 tablets in 24 hours
children 6 to under 12 years of agetake one 30 mg tablet with water every 12 hours; 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

60 mg

adults and children 12 years of age and over         take 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

180 mg

adults and children 12 years of age and over         take 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.


Storage



store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.


Inactive Ingredients



colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.


Principal Display Panel



Container carton label : 180 mg - 30's count


Questions Or Comments?



call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA


* Please review the disclaimer below.