Skip to Content

← See all Fexofenadine Hydrochloride brands

Fexofenadine Hydrochloride by Hetero Labs Limited

Medically reviewed on September 8, 2016

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 30mg
Labeler: Hetero Labs Limited
NDC Code: 68554-5061

Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg

ACTIVE INGREDIENT(S)

(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
Fexofenadine Hydrochloride USP, 180 mg

PURPOSE

Antihistamine

USE(S)

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 DOCTOR IF

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

PREGNANCY/BREASTFEEDING

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

30 mg


adults and children 12 years of age and over
take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in        24 hours
children 6 to under 12 years of age
take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in              24 hours
children under 6 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor

60 mg


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

180 mg


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 printed foil seal under cap is missing
  • This unit-dose package is not child-resistant
  • store between 20º and 25ºC (68º and 77ºF) 
  • protect from excessive moisture

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

QUESTIONS?

Call 1-866-495-1995

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton






Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label







Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil






Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton





Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton








Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label





Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil





Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton





Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton




Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label




Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil




Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton



FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
FERRIC OXIDE RED 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeROUND (biconvex) Size6mm
FlavorImprint Codej;42
Contains    
Packaging
#Item CodePackage Description
1NDC:68554-5061-01 BOTTLE in 1 CARTON
130 TABLET, FILM COATED in 1 BOTTLE
2NDC:68554-5061-11 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:68554-5061-21 BOTTLE in 1 CARTON
3500 TABLET, FILM COATED in 1 BOTTLE
4NDC:68554-5061-510 BLISTER PACK in 1 CARTON
4NDC:68554-5061-410 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:68554-5061-622 BLISTER PACK in 1 CARTON
5NDC:68554-5061-310 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5062
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
FERRIC OXIDE RED 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (biconvex) Size12mm
FlavorImprint Codej;43
Contains    
Packaging
#Item CodePackage Description
1NDC:68554-5062-01 BOTTLE in 1 CARTON
130 TABLET, FILM COATED in 1 BOTTLE
2NDC:68554-5062-11 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:68554-5062-21 BOTTLE in 1 CARTON
3500 TABLET, FILM COATED in 1 BOTTLE
4NDC:68554-5062-57 BLISTER PACK in 1 CARTON
4NDC:68554-5062-410 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:68554-5062-615 BLISTER PACK in 1 CARTON
5NDC:68554-5062-310 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5063
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSES 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
FERRIC OXIDE RED 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULE (biconvex) Size18mm
FlavorImprint Codej;44
Contains    
Packaging
#Item CodePackage Description
1NDC:68554-5063-01 BOTTLE in 1 CARTON
130 TABLET, FILM COATED in 1 BOTTLE
2NDC:68554-5063-11 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
3NDC:68554-5063-21 BOTTLE in 1 CARTON
3500 TABLET, FILM COATED in 1 BOTTLE
4NDC:68554-5063-57 BLISTER PACK in 1 CARTON
4NDC:68554-5063-410 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:68554-5063-615 BLISTER PACK in 1 CARTON
5NDC:68554-5063-310 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
Labeler - Hetero Labs Limited (917261950)

 
Hetero Labs Limited

← See all Fexofenadine Hydrochloride brands

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.

Hide