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Fexofenadine Hydrochloride by Mylan Institutional Inc.

Medically reviewed on March 23, 2017

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg
Labeler: Mylan Institutional Inc.
NDC Code: 51079-547

Drug Facts

 

Non-Drowsy

Indoor/Outdoor Allergy Relief

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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.

Directions - 60 mg (12 Hour Relief)

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

Directions - 180 mg (24 Hour Relief)

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
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
  • protect from excessive moisture

Inactive ingredients

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions?

1-800-848-0462

  • Serious side effects associated with use of this product may be reported to this number.

HOW SUPPLIED

Fexofenadine Hydrochloride Tablets, USP are available containing 60 mg or 180 mg of fexofenadine hydrochloride, USP.

The 60 mg tablets are blue film-coated, round, biconvex, beveled edge, unscored tablets debossed with M over 753 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-547-20 - Unit dose blister packages of 100
(10 cards of 10 tablets each).

The 180 mg tablets are blue film-coated, caplet-shaped, biconvex, beveled edge, unscored tablets debossed with M 755 on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-548-20 - Unit dose blister packages of 100
(10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from excessive moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11117 R4
12/16

Principal Display Panel – 60 mg

NDC 51079-547-20

Fexofenadine HCl
Tablets, USP
60 mg

Antihistamine

Non-Drowsy

Indoor/Outdoor Allergy Relief

12 HR

(See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

S-11114 R4

  • This unit dose package is not child resistant.
  • For institutional use only.
  • Keep this and all drugs out of the reach of children.
  • This container provides light-resistance.
  • See window for lot number and expiration date.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

Principal Display Panel – 180 mg

NDC 51079-548-20

Fexofenadine HCl
Tablets, USP
180 mg

Antihistamine

Non-Drowsy

Indoor/Outdoor Allergy Relief

24 HR

(See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

S-11115 R3

  • This unit dose package is not child resistant.
  • For institutional use only.
  • Keep this and all drugs out of the reach of children.
  • This container provides light-resistance.
  • See window for lot number and expiration date.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-547(NDC:0378-0781)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE (15 MPA.S AT 5%) 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
POVIDONE, UNSPECIFIED 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeM;753
Contains    
Packaging
#Item CodePackage Description
1NDC:51079-547-20100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:51079-547-011 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708102/13/2012
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-548(NDC:0378-0782)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE (15 MPA.S AT 5%) 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
POVIDONE, UNSPECIFIED 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorblueScoreno score
ShapeOVAL (capsule-shaped) Size18mm
FlavorImprint CodeM;755
Contains    
Packaging
#Item CodePackage Description
1NDC:51079-548-20100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:51079-548-011 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708109/27/2011
Labeler - Mylan Institutional Inc. (039615992)

 
Mylan Institutional Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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