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NDC 63187-0921-30 Fexofenadine HCl 180 mg/1 Details

Fexofenadine HCl 180 mg/1

Fexofenadine HCl is a ORAL TABLET, FILM COATED 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: 63187-0921-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	63187-0921
Product ID	63187-921_9d96cb6a-14e9-4dcb-84e4-63d98a716070
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, FILM COATED
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	ANDA204507
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0921-30 (63187092130)

Pricing Information	N/A
NDC Package Code	63187-921-30
Billing NDC	63187092130
Package	30 TABLET, FILM COATED in 1 BOTTLE (63187-921-30)
Marketing Start Date	2017-10-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3b147968-c6a8-4725-89b6-2eb443900e8f Details

ALLERGY Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

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

•: runny nose
•: itchy, watery eyes
•: sneezing
•: 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 180mg 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 bottle is torn or missing
•: store between 20° and 25°C (68° and 77°F)
•: protect from excessive moisture
•: each tablet contains: sodium 8.2 mg
•: this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

Questions or comments?

Call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA,

Repackaged by:

Proficient Rx LP.

Thousand Oaks, CA 91320

Made in USA

Compare to the active ingredient in Allegra® Allergy 24 Hour TabletsAllergy Relief - 24 HOURFEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mgAntihistamineIndoor & Outdoor Allergies

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL

fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-921(NDC:69230-202)
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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-921-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
2	NDC:63187-921-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
3	NDC:63187-921-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
4	NDC:63187-921-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	09/16/2015

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-921) , RELABEL(63187-921)

Revised: 11/2019

Document Id: 9d96cb6a-14e9-4dcb-84e4-63d98a716070

Set id: 3b147968-c6a8-4725-89b6-2eb443900e8f

Version: 3

Effective Time: 20191101