FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and pseudoephedrine hci tablet, extended release

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

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Active ingredient:
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
RUGBY LABORATORIES
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine Nasal decongestant - 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 - temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies - reduces swelling of nasal passages - temporarily relieves sinus congestion and pressure - temporarily restores freer breathing through the nose
Authorization status:
Abbreviated New Drug Application
Authorization number:
0536-1242-07, 0536-1242-34

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and

pseudoephedrine hci tablet, extended release

RUGBY LABORATORIES

----------

Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpos e

Antihistamine

Nasal decongestant

Us e(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

temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory

allergies

reduces swelling of nasal passages

temporarily relieves sinus congestion and pressure

temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

if you have difficulty swallowing

Ask a doctor before use if you have

heart disease

thyroid disease

glaucoma

high blood pressure

diabetes

trouble urinating due to an enlarged prostate gland

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)

the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see

Directions).

Stop use and ask doctor if

an allergic reaction to this product occurs. Seek medical help right away.

symptoms do not improve within 7 days or are accompanied by a fever

you get nervous, dizzy, or sleepless

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

do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years

of age and over

take 1 tablet with a glass of water every 12 hours on an empty stomach; do

not take more than 2 tablets in 24 hours

children under 12 years of

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 individual blister units are torn or opened

store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F)

this product meets the requirements of USP dissolution test 3.

Inactive ingredients

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon

SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.

Ques tions ?

Call 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

Principal Display Panel

Blister carton

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

fexofenadine hcl and pseudoephedrine hci tablet, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -1242(NDC:4359 8 -8 23)

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

6 0 mg

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N) (PSEUDOEPHEDRINE

- UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

120 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

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

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

WHITE (buff white to pale yello w co lo r and o ther layer light red to red co lo r)

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

R;19 5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -1242-34

4 in 1 CARTON

0 8 /26 /20 19

1

5 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 536 -1242-0 7

6 in 1 CARTON

0 8 /26 /20 19

2

5 in 1 BLISTER PACK; 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 6 6 7

0 8 /26 /20 19

RUGBY LABORATORIES

Labeler -

RUGBY LABORAT ORIES (079246066)

Revised: 8/2019

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