Major Pharmaceuticals Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

fexofenadine hydrochloride by

Drug Labeling and Warnings

fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
Major Pharmaceuticals

----------

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 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 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 1

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 2

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 93;7253
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6214-483 in 1 CARTON06/20/201110/31/2019
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 0904-6214-461 in 1 CARTON04/14/201109/30/2019
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 0904-6214-521 in 1 CARTON09/21/201112/31/2019
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 0904-6214-891 in 1 CARTON10/24/201108/31/2019
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 0904-6214-181 in 1 CARTON10/24/201107/04/2016
5120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/14/201112/31/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2019
Document Id: f3241ae4-3fad-4fad-bb53-07c6039c4aba
Set id: c93a9479-02ba-4b5e-a013-9cc826dc3c3b
Version: 3
Effective Time: 20190904
 
Major Pharmaceuticals