SPL v2
SPL
SPL Set ID 6db002e0-ae98-4be2-b410-fbfa6fc9e65f
Route
ORAL
Published
Effective Date 2019-09-11
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: E;44 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2015-09-30
Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Use(s)

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

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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
Other Information
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 200 and 250C (680 and 770F)
  • protect from excessive moisture and light
Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions Or Comments?

call 1-888-287-1915

Principal Display Panel

NDC 49035-995-62



Non-Drowsy

Original Prescription Strength



Fexofenadine HCl Tablets USP,

180 mg/Antihistamine



Allergy Relief



Indoor and Outdoor Allergies

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat                                                                    180 mg EACH  15 TABLETS


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)
Ask A Doctor Before Use If

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

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.

Structured Label Content

Use(s) (USE(S))

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 (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions (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
Other Information (OTHER INFORMATION)
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 200 and 250C (680 and 770F)
  • protect from excessive moisture and light
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Fexofenadine HCl USP, 180 mg

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, stearic acid, titanium dioxide, and yellow iron oxide

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 49035-995-62



Non-Drowsy

Original Prescription Strength



Fexofenadine HCl Tablets USP,

180 mg/Antihistamine



Allergy Relief



Indoor and Outdoor Allergies

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat                                                                    180 mg EACH  15 TABLETS


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)
Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

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

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.598187 · Updated: 2026-03-14T22:55:36.629297