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Fexofenadine hydrochloride by AvKARE, Inc.

Medically reviewed on January 22, 2018

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg
Labeler: AvKARE, Inc.
NDC Code: 42291-296

Fexofenadine Hydrochloride Tablets USP

Active ingredient (in each tablet)

For 60 mg:

Fexofenadine HCl USP, 60 mg

For 180 mg:

Fexofenadine HCl USP, 180 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 aluminium or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health care 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


For 60 mg:
adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor



For 180 mg:

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information
  • store between 20°and 25°C (68°and 77°F)
  • protect from excessive moisture and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions or comments?

 call 1-855-361-3993

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-296-90

Fexofenadine Hydrochloride Tablets USP

Antihistamine

60 mg


90 Tablets

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. LM-1239          AV 09/15 (P)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-297-90

Fexofenadine Hydrochloride Tablets USP

Antihistamine

180 mg


90 Tablets

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478


Mfg. Rev. LM-1241          AV 04/15 (P)

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-296(NDC:13107-066)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
Colororange (Peach) Scoreno score
ShapeCAPSULE (Bevel Edge, Biconvex) Size12mm
FlavorImprint CodeE;42
Contains    
Packaging
#Item CodePackage Description
1NDC:42291-296-9090 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203910/16/2015
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-297(NDC:13107-067)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
Colororange (Peach) Scoreno score
ShapeCAPSULE (Bevel Edge, Biconvex) Size17mm
FlavorImprint CodeE;44
Contains    
Packaging
#Item CodePackage Description
1NDC:42291-297-9090 TABLET, FILM COATED in 1 BOTTLE
2NDC:42291-297-50500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203905/01/2015
Labeler - AvKARE, Inc. (796560394)

 
AvKARE, 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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