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NDC 71205-0531-90 Fexofenadine HCL 180 mg/1 Details

Fexofenadine HCL 180 mg/1

Fexofenadine HCL is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is FEXOFENADINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Related Packages: 71205-0531-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	71205-0531
Product ID	71205-531_d085bace-a71e-42d8-919f-7295afd57dad
Associated GPIs	41550024100350
GCN Sequence Number	033716
GCN Sequence Number Description	fexofenadine HCl TABLET 180 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	46594
HICL Sequence Number	011595
HICL Sequence Number Description	FEXOFENADINE HCL
Brand/Generic	Generic
Proprietary Name	Fexofenadine HCL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA204097
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0531-90 (71205053190)

Pricing Information	N/A
NDC Package Code	71205-531-90
Billing NDC	71205053190
Package	90 TABLET in 1 BOTTLE (71205-531-90)
Marketing Start Date	2021-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f9a7e836-6055-484f-a197-181220428574 Details

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

60 mg

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
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

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

•:  Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
•:  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 OR COMMENTS

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets, USP 180 mg 60s Container Label

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL

fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-531(NDC:69230-300)
Route of Administration	ORAL

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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
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)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	J;44
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-531-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2021
2	NDC:71205-531-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2021
3	NDC:71205-531-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204097	08/19/2016

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-531) , RELABEL(71205-531)

Revised: 4/2022

Document Id: d085bace-a71e-42d8-919f-7295afd57dad

Set id: f9a7e836-6055-484f-a197-181220428574

Version: 2

Effective Time: 20220401