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Fexofenadine Hydrochloride by REMEDYREPACK INC.

Medically reviewed on September 25, 2017

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0746

Drug Facts

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 60 mg

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

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

Other information
  • Tamper Evident: do not use if foil seal under cap is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
  • 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 or comments?

Call 1-877-446-3679 (1-877-4-INFO-RX)

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

PRINCIPAL DISPLAY PANEL

DRUG: Fexofenadine Hydrochloride

GENERIC: fexofenadine

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0746-0

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 18 mm

IMPRINT: M;755

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • FEXOFENADINE HYDROCHLORIDE 180mg in 1

INACTIVE INGREDIENT(S):

  • BUTYLATED HYDROXYANISOLE
  • POLYETHYLENE GLYCOLS
  • POLYSORBATE 80
  • POLYDEXTROSE
  • POVIDONES
  • SODIUM LAURYL SULFATE
  • TITANIUM DIOXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • CROSPOVIDONE (15 MPA.S AT 5%)
  • FD&C BLUE NO. 1
  • HYPROMELLOSES
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • TRIACETIN

FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0746(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 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorblueScoreno score
ShapeOVAL (caplet-shaped) Size18mm
FlavorImprint CodeM;755
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0746-0100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708109/25/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Further information

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

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