FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tabl

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:
PUBLIX SUPER MARKETS INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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 - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat - temporarily relieves 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:
56062-999-30

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE -

fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended

release

PUBLIX SUPER MARKETS INC

----------

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, 60

mg/120 mg

Drug Facts

Active ingredients (in each extended-release

tablet)

Purpose

Fexofenadine HCl, USP 60 mg

Antihistamine

Pseudoephedrine HCl, USP 120 mg

Nasal

Decongestant

Us es

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 relieves 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 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.

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 (1-800-222-1222).

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

do not use if carton is opened or if individual blister units are torn or opened

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

USP dissolution test is pending.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose,

ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, povidone, stearic acid.

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

NDC 56062-999-30

NON-DROWSY

ORIGINAL PRESCRIPTION STRENGTH

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE

PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT

EXTENDED-RELEASE TABLETS, USP

ALLERGY & CONGESTION INDOOR & OUTDOOR ALLERGIES

12-hour relief of:

Nasal & sinus congestion due to colds or allergies

Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies

ACTUAL SIZE

30

EXTENDED-RELEASE

TABLETS

*Compare to the active ingredients

in Allegra-D

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE

HYDROCHLORIDE

fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-9 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

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

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

PO VIDO NE K3 0 (UNII: U725QWY32X)

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

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

ETHYLCELLULO SE, UNSPECIFIED (UNII: 7Z8 S9 VYZ4B)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

Product Characteristics

Color

WHITE, YELLOW

S core

no sco re

S hap e

CAPSULE (bilayer)

S iz e

17mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:56 0 6 2-9 9 9 -

1 in 1 CARTON

0 4/0 1/20 19

1

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 8 18

0 4/0 1/20 19

PUBLIX SUPER MARKETS INC

Labeler -

PUBLIX SUPER MARKET S INC (006922009)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sun Pharmaceutical Industries Limited

6 50 44520 3

ANALYSIS(56 0 6 2-9 9 9 ) , MANUFACTURE(56 0 6 2-9 9 9 )

Revised: 5/2019

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