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FEXOFENADINE HYDROCHLORIDE by Sun Pharmaceutical Industries Limited

Medically reviewed on August 1, 2017

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 30mg
Labeler: Sun Pharmaceutical Industries Limited
NDC Code: 62756-542

Fexofenadine Hydrochloride Tablets, USP

Active ingredient (in each tablet)

For 30 mg:
Fexofenadine HCl, USP 30 mg

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 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.

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

For 30mg:


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

For 60mg:


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

For 180mg:


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
  • safety sealed; do not use if inner safety seal is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

For 30 mg Allergy:

ORIGINAL PRESCRIPTION STRENGTH
NDC 62756-542-88

Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)

Antihistamine
Indoor and Outdoor Allergies
100 Tablets 30 mg each
SUN PHARMA







For 60 mg Allergy:



NDC 62756-543-88
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)

Antihistamine
Indoor and Outdoor Allergies
100 Tablets 60 mg each
SUN PHARMA





For 180 mg Allergy:


NDC 62756-545-88
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 180 mg each
SUN PHARMA



Principal Display Panel

For 30 mg Allergy:

NDC 62756-542-74
ORIGINAL PRESCRIPTION STRENGTH 
NON-DROWSY
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Ages 6 years and Older
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 30 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Principal Display Panel

For 60 mg Allergy:

NDC 62756-543-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 60 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

Principal Display Panel

For 180 mg Allergy:

NDC 62756-545-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 180 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN


FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-542
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
CROSPOVIDONE 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeROUND (circular) Size6mm
FlavorImprint Code542
Contains    
Packaging
#Item CodePackage Description
1NDC:62756-542-8330 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-542-88100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-542-741 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-542-662 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-542-779 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-542-645 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-542-7610 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-542-7815 BLISTER PACK in 1 CARTON
86 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156702/06/2012
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-543
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
CROSPOVIDONE 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize12mm
FlavorImprint Code543
Contains    
Packaging
#Item CodePackage Description
1NDC:62756-543-8330 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-543-88100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-543-741 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-543-662 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-543-779 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-543-645 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-543-7610 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-543-7815 BLISTER PACK in 1 CARTON
86 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156702/06/2012
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-545
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
CROSPOVIDONE 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code545
Contains    
Packaging
#Item CodePackage Description
1NDC:62756-545-8330 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-545-88100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-545-741 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-545-662 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-545-779 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-545-645 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-545-7610 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-545-7815 BLISTER PACK in 1 CARTON
86 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156702/06/2012
Labeler - Sun Pharmaceutical Industries Limited (650172430)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-542, 62756-543, 62756-545), LABEL(62756-542, 62756-545), MANUFACTURE(62756-542, 62756-543, 62756-545), PACK(62756-542, 62756-545)

 
Sun Pharmaceutical Industries Limited

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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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