FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Sun Pharmaceutical Industries, Inc.

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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:

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

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

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

30mg-allergy-2
30mg-allergy-3
30mg-allergy-4
30mg-allergy-5
30mg-allergy-6
30mg-allergy-7
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


60mg-allergy-1

60mg-allergy-2

60mg-allergy-3
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


180mg-allergy-1

180mg-allergy-2

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
30mg-allergy-sb

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
60mg-allergy-sb

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

180mg-allergy-sb

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-542
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUND (circular) Size6mm
FlavorImprint Code 542
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-542-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
2NDC:62756-542-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
3NDC:62756-542-741 in 1 CARTON02/06/2012
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62756-542-662 in 1 CARTON02/06/2012
45 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:62756-542-779 in 1 CARTON02/06/2012
55 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:62756-542-645 in 1 CARTON02/06/2012
66 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:62756-542-7610 in 1 CARTON02/06/2012
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:62756-542-7815 in 1 CARTON02/06/2012
86 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize12mm
FlavorImprint Code 543
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-543-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
2NDC:62756-543-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
3NDC:62756-543-741 in 1 CARTON02/06/2012
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62756-543-662 in 1 CARTON02/06/2012
45 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:62756-543-779 in 1 CARTON02/06/2012
55 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:62756-543-645 in 1 CARTON02/06/2012
66 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:62756-543-7610 in 1 CARTON02/06/2012
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:62756-543-7815 in 1 CARTON02/06/2012
86 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 68401960MK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 545
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62756-545-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
2NDC:62756-545-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
3NDC:62756-545-741 in 1 CARTON02/06/2012
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62756-545-662 in 1 CARTON02/06/2012
45 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:62756-545-779 in 1 CARTON02/06/2012
55 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:62756-545-645 in 1 CARTON02/06/2012
66 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:62756-545-7610 in 1 CARTON02/06/2012
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:62756-545-7815 in 1 CARTON02/06/2012
86 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156702/06/2012
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
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)

Revised: 10/2018
Document Id: e7c52e0c-a809-4d57-9cb6-570029c2a85f
Set id: 04923af6-97fc-4e32-834d-1df643832d7f
Version: 6
Effective Time: 20181026
 
Sun Pharmaceutical Industries, Inc.