FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
OHM LABORATORIES INC.

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Fexofenadine Hydrochloride Tablets, USP 180 mg

Drug Facts

Active ingredient (in each tablet)

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

  • 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 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 (1-800-222-1222).

Directions

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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 or comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

Compare To
the active ingredient of
Allegra® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride
Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour
Relief of:

ohm®

30 Tablets

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
"SEALED for YOUR PROTECTION" IS TORN OR MISSING

Principal Display Panel - 180 mg Tablet Bottle Carton
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-998
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize17mm
FlavorImprint Code 545
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-998-301 in 1 CARTON04/29/2022
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51660-998-551 in 1 CARTON04/29/2022
2150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156704/29/2022
Labeler - OHM LABORATORIES INC. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650445203MANUFACTURE(51660-998)

Revised: 4/2022
Document Id: 091c0633-b5d5-462a-8aa0-36ae245dbbbc
Set id: 1a1afa95-570d-456e-b436-a0fcfaf68517
Version: 1
Effective Time: 20220426
 
OHM LABORATORIES INC.