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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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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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