Fexofenadine Hydrochloride Tablets Usp,180 Mg

Fexofenadine Hydrochloride Tablets Usp,180 Mg
SPL v6
SPL
SPL Set ID 95d420ea-6337-304f-54c3-0c75be1608e2
Route
ORAL
Published
Effective Date 2015-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Mannitol Powdered Cellulose Fd&c Red No. 40 Hypromellose 2910 (6 Mpa.s) Ferrosoferric Oxide Polyethylene Glycol 400 Titanium Dioxide Starch, Corn

Identifiers & Packaging

Marketing Status
ANDA Active Since 2011-04-13
Description

Fexofenadine Hydrochloride USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine Hydrochloride USP, 180 mg

Use(s)

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 51945-4

Bottle Carton Label

Storage

  • store between 20° and 25°C (68° and 77°F)

  • protect from excessive moisture

  • this product meets the requirements of USP Dissolution Test 2

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
Do Not Use

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

Questions?

Call 1-888-375-3784

Other Information

(blister only) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

(bottles only) safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

Active Ingredient(s)

Fexofenadine Hydrochloride USP, 180 mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black,magnesium stearate,mannitol, polyethylene glycol, powdered cellulose and titanium dioxide

When Using This Product
  • do not take more than directed
  • do not take at the same time as aluminum 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.

Blister Carton Label: 15 Count

Blister Carton Label

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.

Ask A Doctor Before Use If You Have

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

Structured Label Content

Use(s)

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 51945-4 (51945-4)

Bottle Carton Label

Purpose

Antihistamine

Storage

  • store between 20° and 25°C (68° and 77°F)

  • protect from excessive moisture

  • this product meets the requirements of USP Dissolution Test 2

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
Do Not Use (Do not use)

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

Questions?

Call 1-888-375-3784

Other Information (Other information)

(blister only) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

(bottles only) safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

Active Ingredient(s) (Active ingredient(s))

Fexofenadine Hydrochloride USP, 180 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black,magnesium stearate,mannitol, polyethylene glycol, powdered cellulose and titanium dioxide

When Using This Product (When using this product)
  • do not take more than directed
  • do not take at the same time as aluminum 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.

Blister Carton Label: 15 Count (Blister Carton Label: 15 count)

Blister Carton Label

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.

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: 2026-02-15T12:00:58.391592 · Updated: 2026-03-14T23:01:12.726296