Fexofenadine Hydrochloride
FDA Label NDC 68210-5034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Fexofenadine Hydrochloride (NDC 68210-5034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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