FEXOFENADINE HYDROCHLORIDE tablet

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

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Active ingredient:
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Available from:
Dr. Reddy's Laboratories Inc.
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 - itchy, watery eyes - sneezing - itching of the nose or throat
Authorization status:
Abbreviated New Drug Application
Authorization number:
43598-936-01, 43598-936-30

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FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet

Dr. Reddy's Laboratories Inc.

----------

Fexofenadine HCl Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpos e

Antihistamine

Us e(s )

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 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

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

this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron

oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Ques tions ?

Call 1-888-375-3784

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Container:

Carton:

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4359 8 -9 36 (NDC:55111-78 3)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Fexo fena dine Hydro chlo ride (UNII: 2S0 6 8 B75ZU) (FEXOFENADINE - UNII:E6 58 2LOH6 V)

Fexo fenadine Hydro chlo ride

6 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

ma nnito l (UNII: 3OWL53L36 A)

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

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

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

po lyethylene g lyco l 4 0 0 (UNII: B6 9 78 9 4SGQ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

Dr. Reddy's Laboratories Inc.

Product Characteristics

Color

PINK

S core

no sco re

S hap e

OVAL

S iz e

Flavor

Imprint Code

19 3;R

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4359 8 -9 36 -30

1 in 1 CARTON

12/0 1/20 20

1

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

2

NDC:4359 8 -9 36 -0 1

1 in 1 CARTON

12/0 1/20 20

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

ANDA0 76 50 2

12/0 1/20 20

Labeler -

Dr. Reddy's Laboratories Inc. (802315887)

Revised: 9/2020

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