FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT(IN EACH CAPLET) FEXOFENADINE HCI 180 MG
- PURPOSEANTIHISTAMINE
- USESTEMPORARILY 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 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 ALUMINUM OR MAGNESIUM ANTACIDS ■ DO NOT TAKE WITH FRUIT JUICES (SEE DIRECTIONS)
- STOP USE AND ASK A DOCTOR IFAN 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 CAPLET WITH WATER ONCE A DAY; DO NOT TAKE MORE THAN 1 CAPLET 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?1-888-333-9792
- PRINCIPAL DISPLAY PANEL
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals 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 Caplet) Fexofenadine Hci 180 Mg
Purposeantihistamine
Usestemporarily 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 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 Aluminum Or Magnesium Antacids ■ Do Not Take With Fruit Juices (See Directions)
Stop Use And Ask A Doctor Ifan 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 Caplet With Water Once A Day; Do Not Take More Than 1 Caplet 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?1-888-333-9792
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