SPL v3
SPL
SPL Set ID dd7a5c55-f834-4aa2-8cdf-a62154ce7dde
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 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: E;42 Shape: capsule Color: orange Size: 17 mm Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2016-10-05
Description

Fexofenadine HCl USP, 180 mg Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Medication Information

Purpose


Antihistamine

Description

Fexofenadine HCl USP, 180 mg Fexofenadine HCl USP, 60 mg

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

.

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






Do Not Use

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

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

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.

Active Ingredient(in Each Tablet)


Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg

Ask A Doctor Before Use If You Have

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

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;R unny nose; Itchy, Watery Eyes & Itchy Nose or Throat

15 Tablets 180 mg each











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;R unny nose; Itchy, Watery Eyes & Itchy Nose or Throat

24 Tablets 60 mg each





Structured Label Content

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


Purpose


Antihistamine

Warnings

.

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






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)
  • 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 (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 1-855-274-4122

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 right away.

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


Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 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.

Principal Display Panel 180 Mg 15 Ct (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;R unny nose; Itchy, Watery Eyes & Itchy Nose or Throat

15 Tablets 180 mg each











Principal Display Panel 60 Mg 24 Ct (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;R unny nose; Itchy, Watery Eyes & Itchy Nose or Throat

24 Tablets 60 mg each





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:51.595440 · Updated: 2026-03-14T22:55:36.629297