Fexofenadine Hydrochloride
FDA Label NDC 54257-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magno-humphries Labs, Inc. for the product Fexofenadine Hydrochloride (NDC 54257-001). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant or breast-feeding, 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 respiratory allergies:

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

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 (1-800-222-1222) right away.

Directions




adults and children 12 years of age and over 1 tablet with water 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

  • 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 toll-free 1-800-935-6737

Principal Display Panel



*Compare to 24 Hour Allegra® Allergy active ingredient




Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy Relief
Non-Drowsy 24 hour Allergy

Relief of:  Sneezing , Runny nose
Itchy, Watery Eyes &
Itchy Nose or Throat



Original Prescription Strength


150 Tablets 180 mg each



Principle Display Panel-180 mg-150s Count (Fexofenadine Fig 1)

Principle Display Panel-180 mg-150s Count (Fexofenadine Fig 1)


Drug Facts-continue-180 mg-150s Coun (Fexofenadine Fig 2)

Drug Facts-continue-180 mg-150s Coun (Fexofenadine Fig 2)



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