Fexofenadine hydrochloride tablet, film coated

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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

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

Warnings

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

Ask a doctor before use if

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

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 aPoison Control Center right away.

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
adults65 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 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, stearic acid, titanium dioxide, and yellow iron oxide

Questions or comments?

call 1- 888-287-1915

Ingredients and appearance - Product information

Fexofenadine hydrochloride tablet, film coated- Fexofenadine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 49035-995
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 180 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Ferric oxide red ( UNII: 1K09F3G675)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color ORANGE (Peach) Shape CAPSULE (Bevel Edge, Biconvex)
Size 17 mm Score 1
Imprint Code E;44

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202039 USA

Labeler - Wal-Mart Stores, Inc( 051957769)

Establishment

Name ID/FEI Business Operations
Wal-Mart Stores, Inc 051957769 MANUFACTURE( 49035-995)

Principal display panel

NDC 49035-995-62

Non-Drowsy
Original Prescription Strength

Fexofenadine HCl Tablets USP,
180 mg/Antihistamine

Allergy Relief

Indoorand Outdoor Allergies
Relief of:

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