SPL v2
SPL
SPL Set ID 140073ad-3153-41f4-b6a3-8a606e35f435
Route
ORAL
Published
Effective Date 2019-09-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Anhydrous Lactose Silicon Dioxide Croscarmellose Sodium Hypromelloses Lactose Monohydrate Starch, Pregelatinized Corn Stearic Acid Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: E;44 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2015-01-15
Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose


Antihistamine

Description

Fexofenadine HCl USP, 180 mg

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


Warnings




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 age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
Do Not Use


if you have ever had an allergic reaction to this product or any of its ingredients

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 ,  R unny nose

Itchy, Watery Eyes &

Itchy Nose or Throat





Original Prescription Strength





150 Tablets 180 mg each











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.

Active Ingredient(in Each Tablet)


Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have


kidney disease. Your doctor should determine if you need a different dose.

Structured Label Content

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


Purpose


Antihistamine

Warnings




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 age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
Do Not Use (Do not use)


if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)
  • store between 20°and 25°C (68°and 77°F)
  • protect from excessive moisture and light
Inactive Ingredients (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? (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 ,  R unny nose

Itchy, Watery Eyes &

Itchy Nose or Throat





Original Prescription Strength





150 Tablets 180 mg each











When Using This Product (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 (Stop use and ask doctor if)


an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)


ask a health professional before use.

Keep Out of Reach of Children (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.

Active Ingredient(in Each Tablet) (Active ingredient(in each tablet))


Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)


kidney disease. Your doctor should determine if you need a different dose.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.110122 · Updated: 2026-03-14T22:55:36.629297