FEXOFENADINE HCL - fexofenadine hcl tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Available from:
NorthStar RxLLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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  if you have ever had an allergic reaction to this product or any of its ingredients.  you have kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use.
Authorization status:
Abbreviated New Drug Application
Authorization number:
16714-899-01, 16714-899-02

FEXOFENADINE HCL - fexofenadine hcl tablet

NorthStar RxLLC

----------

Fexofenadine Hydrochloride Tablets USP, 180 mg

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

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

Tamper-Evident: Do not use if printed foil seal under cap is 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.

Ques tions ?

Call 1-800-206-7821

Manufactured for:

Northstar Rx LLC

Memphis, TN 38141.

Manufactured by:

Hetero Labs Limited,

Unit V, Polepally, Jadcherla,

Mahabubnagar - 509 301, India.

Mfg. Lic. No.: 50/MN/AP/2009/F/R

Issued: 04/2019

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container label

Fexofenadine Hydrochloride Tablets USP, 180 mg - 30s container carton

Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container label

Fexofenadine Hydrochloride Tablets USP, 180 mg - 100s container carton

FEXOFENADINE HCL

fexofenadine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:16 714-8 9 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FEXO FENADINE HYDRO CHLO RIDE (UNII: 2S0 6 8 B75ZU) (FEXOFENADINE -

UNII:E6 58 2LOH6 V)

FEXOFENADINE

HYDROCHLORIDE

18 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

NorthStar RxLLC

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 6 0 0 0 (UNII: 30 IQX730 WE)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

STARCH, CO RN (UNII: O8 232NY3SJ)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

J;44

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:16 714-8 9 9 -0 1

1 in 1 CARTON

0 2/18 /20 19

1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:16 714-8 9 9 -0 2

1 in 1 CARTON

0 2/18 /20 19

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 40 9 7

0 2/18 /20 19

Labeler -

NorthStar RxLLC (830546433)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hetero Labs Limited Unit V

6 50 452530

ANALYSIS(16 714-8 9 9 ) , MANUFACTURE(16 714-8 9 9 )

Revised: 4/2019

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