FDA Label for Fexofenadine Hcl

View Indications, Usage & Precautions

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)FEXOFENADINE HCL 180 MG
    3. PURPOSE ANTIHISTAMINE
    4. 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
    5. WARNINGSDO NOT USEIF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.
    6. ASK A DOCTOR BEFORE USE IF YOU HAVEKIDNEY DISEASE. YOUR DOCTOR SHOULD DETERMINE IF YOU NEED A DIFFERENT DOSE.
    7. 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)
    8. STOP USE AND ASK A DOCTORIF AN ALLERGIC REACTION TO THIS PRODUCT OCCURS. SEEK MEDICAL HELP RIGHT AWAY.
    9. IF PREGNANT OR BREAST-FEEDING,ASK A HEALTH PROFESSIONAL BEFORE USE.
    10. KEEP OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY (1-800-222-1222).
    11. DIRECTIONS- ADULTS AND CHILDREN 12 YEARS 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 AGE                            :  DO NOT USE    - ADULTS 65 YEARS OF AGE AND OLDER                         :  ASK A DOCTOR - CONSUMERS WITH KIDNEY DISEASE                         :  ASK A DOCTOR
    12. OTHER INFORMATION •  STORE BETWEEN 20º AND 25ºC (68º AND 77ºF) •  PROTECT FROM EXCESSIVE MOISTURE
    13. INACTIVE INGREDIENTS COLLOIDAL ANHYDROUS SILICA, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, HYPROMELLOSE, IRON OXIDE RED, IRON OXIDE YELLOW, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, PREGELATINIZED STARCH, PURIFIED WATER, TITANIUM DIOXIDE
    14. QUESTIONS OR COMMENTS? 833-358-6431
    15. PACKAGE AND PRINCIPLE DISPLAY

Fexofenadine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services, 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.

Drug Facts




Active Ingredient (In Each Tablet)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




Warningsdo Not Useif You Have Ever Had An Allergic Reaction To This Product Or Any Of Its Ingredients.




Ask A Doctor Before Use If You Havekidney 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 Doctorif 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 (1-800-222-1222).




Directions- Adults And Children 12 Years 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 Age                            :  Do Not Use    - Adults 65 Years Of Age And Older                         :  Ask A Doctor - Consumers With Kidney Disease                         :  Ask A Doctor




Other Information •  Store Between 20º And 25ºc (68º And 77ºf) •  Protect From Excessive Moisture




Inactive Ingredients Colloidal Anhydrous Silica, Colloidal Silicon Dioxide, Croscarmellose Sodium, Hypromellose, Iron Oxide Red, Iron Oxide Yellow, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Purified Water, Titanium Dioxide




Questions Or Comments? 833-358-6431




Package And Principle Display




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