Fexofenadine HCL by PD-Rx Pharmaceuticals, Inc. FEXOFENADINE HCL tablet

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 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

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

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL
fexofenadine hcl tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72789-196-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/06/2021
2	NDC: 72789-196-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2022
3	NDC: 72789-196-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/14/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204097	02/18/2019

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Name	Address	ID/FEI	Business Operations
Establishment
PD-Rx Pharmaceuticals, Inc.		156893695	repack(72789-196)

Fexofenadine HCL by