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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 CAPLET)
    2. PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY CHATTEM, INC, A SANOFI COMPANY, OWNER OF THE REGISTERED TRADEMARK ALLEGRA®.

Fexofenadine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Nuvicare Llc. 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 Caplet)



Fexofenadine HCl 180 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose  sneezing  itchy, watery eyes  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.


Otc - When Using



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 (1-800-222-1222) 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 age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor


Other Safety Information



Other information  store between 20° and 25°C (68° and 77°F)  protect from excessive moisture


Inactive Ingredient



Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, povidone, pregelatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.


Otc - Questions



Call 1(718) 337-8733 or visit: [email protected]


This Product Is Not Manufactured Or Distributed By Chattem, Inc, A Sanofi Company, Owner Of The Registered Trademark Allegra®.




* Please review the disclaimer below.