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NDC 71335-0506-02 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 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: 71335-0506-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	71335-0506
Product ID	71335-0506_329b1831-418e-4de0-acf2-4269f03d7947
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 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	Bryant Ranch Prepack
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	2023-12-31

Package

Package Images

NDC 71335-0506-02 (71335050602)

Pricing Information	N/A
NDC Package Code	71335-0506-2
Billing NDC	71335050602
Package	15 TABLET, FILM COATED in 1 BOTTLE (71335-0506-2)
Marketing Start Date	2018-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 329b1831-418e-4de0-acf2-4269f03d7947 Details

ALLERGY Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP, 60mg and 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 (1800-222-1222).

Directions

FOR 60mg
adults and children 12 years of age and over	take two 60mg tablets with water evrery 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


FOR 180mg
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 (for 180mg)
each tablet contains: sodium 2.7 mg (for 60mg)
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,

Made in USA

HOW SUPPLIED

NDC: 71335-0506-1: 30 Tablets in a BOTTLE

NDC: 71335-0506-2: 15 Tablets in a BOTTLE

NDC: 71335-0506-3: 60 Tablets in a BOTTLE

NDC: 71335-0506-4: 90 Tablets in a BOTTLE

NDC: 71335-0506-5: 5 Tablets in a BOTTLE

NDC: 71335-0506-6: 180 Tablets in a BOTTLE

NDC: 71335-0506-7: 100 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Fexofenadine Hcl 180mg Tablet

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL

fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0506(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:71335-0506-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2018
2	NDC:71335-0506-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2018
3	NDC:71335-0506-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
4	NDC:71335-0506-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2020
5	NDC:71335-0506-5	5 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
6	NDC:71335-0506-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
7	NDC:71335-0506-7	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2018

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0506) , RELABEL(71335-0506)

Revised: 2/2022

Document Id: 329b1831-418e-4de0-acf2-4269f03d7947

Set id: 329b1831-418e-4de0-acf2-4269f03d7947

Version: 6

Effective Time: 20220209