FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
Mylan Institutional Inc.

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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.

Fexofenadine Hydrochloride Tablets, USP 60 mg Carton Label
Outer Carton Label

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 Tablets, USP 120 mg Carton Label
Outer Carton Label
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-547(NDC:0378-0781)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint Code M;753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-547-20100 in 1 BOX, UNIT-DOSE02/13/201202/28/2022
1NDC:51079-547-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708102/13/201202/28/2022
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-548(NDC:0378-0782)
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (capsule-shaped) Size18mm
FlavorImprint Code M;755
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-548-20100 in 1 BOX, UNIT-DOSE09/27/201102/28/2022
1NDC:51079-548-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708109/27/201102/28/2022
Labeler - Mylan Institutional Inc. (039615992)

Revised: 11/2021
 
Mylan Institutional Inc.