FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Granules India Ltd

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Fexofenadine HCl Tablets USP, 60 mg and 180 mg

ACTIVE INGREDIENT(S)

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

PURPOSE

Antihistamine

USE(S)

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 a 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

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 (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

QUESTIONS OR COMMENTS

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Manufactured By:
Granules India Limited    
Hyderabad-500 081, India
MADE IN INDIA

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

PRINCIPAL DISPLAY PANEL

fexodenadine-label1-jpgfexofenadine-60mg-10s-carton



fexofenadine-180mg-10s-carton.jpg

Fexofenadine-USP-60mg-Label

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-765
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code G5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-765-511 in 1 CARTON12/18/2020
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62207-765-491000 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
3NDC:62207-765-608 in 1 CARTON12/18/2020
39 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62207-765-885 in 1 BOX11/17/2021
410000 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107512/18/2020
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-766
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeOVAL (Capsule-shaped) Size17mm
FlavorImprint Code G6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-766-511 in 1 CARTON12/18/2020
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62207-766-491000 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
3NDC:62207-766-587 in 1 CARTON12/18/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62207-766-3525000 in 1 BOX; Type 0: Not a Combination Product12/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107512/18/2020
Labeler - Granules India Ltd (915000087)

Revised: 1/2023
Document Id: f38957f6-56f9-583b-e053-2995a90a473a
Set id: 3151bc6d-b40b-4200-a5cf-e57b6791d92a
Version: 6
Effective Time: 20230131
 
Granules India Ltd