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fexofenadine hydrochloride by Major Pharmaceuticals

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6214

Major Pharmaceuticals Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

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 overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information
  • do not use if blister unit is broken or torn (Use for Blister Configurations Only)
  • do not use if printed foil under cap is broken or missing (Use for Bottle Configurations Only)
  • store at 20°-25°C (68°-77°F)
  • 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

Package/Label Principal Display Panel

COMPARE TO active ingredient of ALLEGRA® ALLERGY TABLETS

Original Prescription Strength

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

Antihistamine
ALLERGY

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Indoor & Outdoor Allergies

24 HOUR

Non-Drowsy

actual size

180 mg EACH

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 1

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 2

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6214
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code93;7253
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6214-483 BLISTER PACK (BLISTER PACK) in 1 CARTON
15 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:0904-6214-461 BOTTLE (BOTTLE) in 1 CARTON
230 TABLET, FILM COATED (TABLET) in 1 BOTTLE
3NDC:0904-6214-521 BOTTLE (BOTTLE) in 1 CARTON
360 TABLET, FILM COATED (TABLET) in 1 BOTTLE
4NDC:0904-6214-891 BOTTLE (BOTTLE) in 1 CARTON
490 TABLET, FILM COATED (TABLET) in 1 BOTTLE
5NDC:0904-6214-181 BOTTLE (BOTTLE) in 1 CARTON
5120 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/14/2011
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Medically reviewed on Nov 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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