Fexofenadine Hydrochloride
FDA Label NDC 0363-0097

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co for the product Fexofenadine Hydrochloride (NDC 0363-0097). 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

Fexofenadine HCl USP, 60 mg

Purpose


Antihistamine

Uses

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

  • 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 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


adults and children 12 years of age 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

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or opened
  • 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- 60 Mg 24 Ct

NDC 0363-0095-24
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
12 HOUR ALLERGY
Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
12 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
24 Tablets 60 mg each

Walfex-fig1 (Walfex Fig1)

Walfex-fig1 (Walfex Fig1)



Principal Display Panel- 180 Mg 15 Ct


NDC 0363-0097-53
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
24 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of  Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
15 Tablets 180 mg each

Walfex-fig2 (Walfex Fig2)

Walfex-fig2 (Walfex Fig2)






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