FEXOFENADINE HCL- fexofenadine hcl tablet 
PD-Rx Pharmaceuticals, Inc.

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Fexofenadine Hydrochloride Tablets USP, 180 mg

ACTIVE INGREDIENT(S) in each tablet

Fexofenadine hydrochloride USP, 180 mg

PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


§  runny nose

§  sneezing

§  itchy, watery eyes

§  itching of the nose or throat


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.

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 age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

Other information

        • Tamper-Evident: Do not use if seal is missing from bottle.
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture


Inactive ingredients

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Questions?

Call 1-800-206-7821

HOW SUPPLIED

Fexofenadine HCL, 180 mg are pink, capsules debossed with 'J 44' and are supplied as follows:

NDC 72789-196-10 in bottles of 10 tablets

NDC 72789-196-30 in bottles of 30 tablets

NDC 72789-196-90 in bottles of 90 tablets

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 180 mg


image

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-196(NDC:16714-899)
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
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-196-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/06/2021
2NDC:72789-196-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2022
3NDC:72789-196-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409702/18/2019
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-196)

Revised: 3/2023
Document Id: f6e158c9-9d02-13e9-e053-6394a90a1843
Set id: 07460764-43fa-49fd-ae77-d4571cb9f944
Version: 7
Effective Time: 20230314
 
PD-Rx Pharmaceuticals, Inc.