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NDC 71335-0483-03 Fexofenadine hydrochloride 180 mg/1 Details

Fexofenadine hydrochloride 180 mg/1

Fexofenadine hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 71335-0483-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	71335-0483
Product ID	71335-0483_0d3ec8c9-4703-488b-98c9-1b0935275d78
Associated GPIs	41550024100350
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Fexofenadine hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA202039
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71335-0483-03 (71335048303)

Pricing Information	N/A
NDC Package Code	71335-0483-3
Billing NDC	71335048303
Package	60 TABLET, FILM COATED in 1 BOTTLE (71335-0483-3)
Marketing Start Date	2017-01-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6a401b63-1d8d-46ec-933a-3d6bc8957170 Details

Active ingredient(in each tablet)

Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
do not take with fruit juices (see directions)

Stop use and ask 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

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 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 bottle is torn or missing
store between 20°and 25°C (68°and 77°F)
protect from excessive moisture and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

call 1-855-274-4122

HOW SUPPLIED

Product: 71335-0483

NDC: 71335-0483-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-3 60 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-4 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-5 5 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-6 180 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-7 100 TABLET, FILM COATED in a BOTTLE

Fexofenadine Hcl 180mg Tablet

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0483(NDC:58602-711)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	CAPSULE (Bevel Edge, Biconvex)	Size	17mm
Flavor		Imprint Code	E;44
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0483-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
2	NDC:71335-0483-7	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
3	NDC:71335-0483-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
4	NDC:71335-0483-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
5	NDC:71335-0483-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
6	NDC:71335-0483-5	5 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017
7	NDC:71335-0483-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202039	01/15/2015

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0483) , RELABEL(71335-0483)

Revised: 1/2020

Document Id: 0d3ec8c9-4703-488b-98c9-1b0935275d78

Set id: 6a401b63-1d8d-46ec-933a-3d6bc8957170

Version: 5

Effective Time: 20200119