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 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:

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

Ask a doctor before use if you have

When using this product

Stop use and ask doctor if

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 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

Inactive ingredients


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

Questions?


Call toll free 1-800-818-4555 weekdays.

Principal Display Panel


For 180 mg : Label

NDC 62756-545-15

Fexofenadine Hydrochloride Tablets, USP

180 mg

HIVES

(24 Hour)

Reduces HIVES and Relieves ITCHING due to hives


Antihistamine

ORIGINAL PRESCRIPTION STRENGTH

NON-DROWSY

30 Tablets

180 mg each

Actual Size



bottle



Principal Display Panel


For 180 mg : Carton

NDC 62756-545-15

Fexofenadine Hydrochloride Tablets, USP

180 mg

HIVES

(24 Hour)

Reduces HIVES and Relieves ITCHING due to hives

 
Antihistamine

NON-DROWSY

30 Tablets

180 mg each

Actual Size



bottle-carton

Principal Display Panel


For 180 mg : Blister Pack

NDC 62756-545-15

ORIGINAL PRESCRIPTION STRENGTH
 
NON-DROWSY

Fexofenadine Hydrochloride Tablets, USP

180 mg

HIVES

(24 Hour)

Reduces HIVES and Relieves ITCHING due to hives

 
Antihistamine

5 (1 x 5) Tablets

180 mg each

Actual Size

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN



blister

Principal Display Panel

For 180 mg : Blister Foil

Fexofenadine Hydrochloride Tablets, USP

24 Hour

180 mg

HIVES

Antihistamine

Mfg. by: Sun Pharmaceutical Ind. Ltd., India.



foil
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
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:62756-545-271 in 1 CARTON06/30/2022
1NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:62756-545-942 in 1 CARTON06/30/2022
2NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:62756-545-253 in 1 CARTON06/30/2022
3NDC:62756-545-315 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:62756-545-1530 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
5NDC:62756-545-1745 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
6NDC:62756-545-1870 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
7NDC:62756-545-1990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
8NDC:62756-545-20150 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
9NDC:62756-545-21180 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
10NDC:62756-545-22300 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156706/30/2022
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-545) , MANUFACTURE(62756-545)

Revised: 6/2022
Document Id: ba7aefbb-bb1a-44fd-b62e-53aeb9cbbaab
Set id: 47826458-4f7f-486b-aec4-ae48c3f94f5e
Version: 10
Effective Time: 20220627
 
Sun Pharmaceutical Industries, Inc.