Skip to Content

← See all FEXOFENADINE HYDROCHLORIDE brands

FEXOFENADINE HYDROCHLORIDE by Sun Pharmaceutical Industries Limited

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

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use
  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 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

For 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

For 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
  • 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 Hives Relief:



NDC 62756-542-16
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
HIVES
(12 Hour)
Antihistamine

Relief of ITCHING Due to Hives
100 Tablets 30 mg each
SUN PHARMA 














For 60 mg Hives Relief:

NDC 62756-543-16 Fexofenadine Hydrochloride Tablets, USP
60 mg
HIVES
(12 Hour)
Antihistamine

Relief of ITCHING Due to Hives
100 Tablets 60 mg each
SUN PHARMA





For 180 mg Hives Relief:



NDC 62756-545-16
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Antihistamine
Relief of ITCHING Due to Hives
100 Tablets 180 mg each
SUN PHARMA




Principal Display Panel

For 30 mg Hives Relief:

NDC 62756-542-27
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
HIVES
(12 Hour)
Antihistamine
Relief of ITCHING Due to Hives
Ages 6 years and Older
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 Hives Relief:

NDC 62756-543-27
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
60 mg
HIVES
(12 Hour)
Antihistamine
Relief of ITCHING Due to Hives
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 Hives Relief:

NDC 62756-545-27
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Antihistamine
Relief of ITCHING Due to Hives
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:62756-542-1530 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-542-16100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-542-271 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-542-942 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-542-289 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-542-955 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-542-2910 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-542-3015 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:62756-543-1530 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-543-16100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-543-271 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-543-942 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-543-289 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-543-955 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-543-2910 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-543-3015 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:62756-545-1530 TABLET, FILM COATED in 1 BOTTLE
2NDC:62756-545-16100 TABLET, FILM COATED in 1 BOTTLE
3NDC:62756-545-271 BLISTER PACK in 1 CARTON
35 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:62756-545-942 BLISTER PACK in 1 CARTON
45 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:62756-545-289 BLISTER PACK in 1 CARTON
55 TABLET, FILM COATED in 1 BLISTER PACK
6NDC:62756-545-955 BLISTER PACK in 1 CARTON
66 TABLET, FILM COATED in 1 BLISTER PACK
7NDC:62756-545-2910 BLISTER PACK in 1 CARTON
76 TABLET, FILM COATED in 1 BLISTER PACK
8NDC:62756-545-3015 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(62756-543), MANUFACTURE(62756-542, 62756-543, 62756-545), PACK(62756-543)

Revised: 08/2017
 
Sun Pharmaceutical Industries 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