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NDC 71335-0290-04 Fexofenadine Hydrochloride 60 mg/1 Details

Fexofenadine Hydrochloride 60 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: 71335-0290-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	71335-0290
Product ID	71335-0290_137a1574-aa3a-4500-b906-6baac159dd2f
Associated GPIs
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 HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	60
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	ANDA076447
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-0290-04 (71335029004)

Pricing Information	N/A
NDC Package Code	71335-0290-4
Billing NDC	71335029004
Package	90 TABLET, FILM COATED in 1 BOTTLE (71335-0290-4)
Marketing Start Date	2013-03-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 137a1574-aa3a-4500-b906-6baac159dd2f Details

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 (1-800-222-1222).

Directions

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

Other information

•: do not use if carton is opened or printed foil under cap is broken or missing
•: store between 20°-25°C (68°-77°F)
•: protect from excessive moisture
•: this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

HOW SUPPLIED

NDC: 71335-0290-1: 30 Tablets in a BOTTLE

NDC: 71335-0290-2: 10 Tablets in a BOTTLE

NDC: 71335-0290-3: 60 Tablets in a BOTTLE

NDC: 71335-0290-4: 90 Tablets in a BOTTLE

NDC: 71335-0290-5: 14 Tablets in a BOTTLE

NDC: 71335-0290-6: 20 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Fexofenadine Hcl 60mg Tablet

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE

fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0290(NDC:45802-425)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	93;7252
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0290-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013
2	NDC:71335-0290-2	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013
3	NDC:71335-0290-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013
4	NDC:71335-0290-4	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013
5	NDC:71335-0290-5	14 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013
6	NDC:71335-0290-6	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	08/08/2011

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0290) , RELABEL(71335-0290)

Revised: 12/2021

Document Id: 137a1574-aa3a-4500-b906-6baac159dd2f

Set id: 137a1574-aa3a-4500-b906-6baac159dd2f

Version: 4

Effective Time: 20211227