SPL v1
SPL
SPL Set ID d5914c05-e8db-4c79-82d0-a279d1304118
Route
ORAL
Published
Effective Date 2019-06-20
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 resporatory allergies:

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


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
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 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 1-844-428-2538

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





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 10 Ct)


NDC 10202-701-66



*Compare to Active Ingredient in 24 Hour Allegra®

Original Prescription Strength Non-Drowsy


Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine

24 hour relief of Indoor & Outdoor Allergies:

Sneezing 

R
unny nose

Itchy, Watery Eyes

Itchy Nose or Throat








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

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
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 missing
  • 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 1-844-428-2538

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





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 10 Ct) (Principal Display Panel (180 mg 10 ct))


NDC 10202-701-66



*Compare to Active Ingredient in 24 Hour Allegra®

Original Prescription Strength Non-Drowsy


Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine

24 hour relief of Indoor & Outdoor Allergies:

Sneezing 

R
unny nose

Itchy, Watery Eyes

Itchy Nose or Throat








Advanced Ingredient Data


Raw Label Data

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