Fexofenadine Hydrochloride
FDA Label NDC 55315-355

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Freds for the product Fexofenadine Hydrochloride (NDC 55315-355). 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 active ingredient(in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Tablet)


Fexofenadine HCl USP, 180 mg

Purpose


Antihistamine

Uses


temporarily relieves these symptoms due to hay fever or other upper resporatory alleergies:

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

    •  

Warnings


 

Do Not Use


if 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 aluminium or magnesium antacids
  • do not take with fruit juices (see directions)

Stop Use And Ask Doctor If


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.

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 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 printed foil inner seal on bottle is torn or missing
  • store between 20°and 25°C (68°and 77°F)
  • protect from excessive moisture and light

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions Or Comments?


 call 1-855-274-4122

Principal Display Panel



NDC 55315-355-31

Original Prescription Strength
Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy
Indoor & Outdoor Allergies

24 Hours Relief of: 

 Sneezing
 Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSING

30 Tablets 180 mg each



Fexofenadine Hydrochloride Tablets-180 mg -30's Count (Fexofenadine Fig1)

Fexofenadine Hydrochloride Tablets-180 mg -30's Count (Fexofenadine Fig1)


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