Allergy relief tablet, film coated

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

kidney 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 aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask a 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 (1-800-222-1222).

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

  • do not use if printed blister unit is broken or torn
  • store at 20-25C (68-77F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Allergy relief tablet, film coated- Fexofenadine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37012-571
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
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Ferrosoferric oxide ( UNII: XM0M87F357)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color ORANGE (peach) Size 12 mm
Shape ROUND Score 1
Imprint Code 93;7253

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076447 USA

Labeler - Shopko Stores Operating Co., LLC( 023252638)

Package/label principal display panel

Compare to Allegra ®Allergy active ingredient

ALLERGY RELIEF

Fexofenadine Hydrochloride Tablets 180 mg / Antihistamine

Indoor/Outdoor Allergy Relief

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Nose or Throat

Non-Drowsy

24 HOUR

15 TABLETS

Actual Size