PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated, extended release

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

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Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Publix Super Markets Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves sinus congestion and pressure
Authorization status:
Abbreviated New Drug Application
Authorization number:
56062-204-21

PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film

coated, extended release

Publix Super Markets Inc

----------

Pseudoephedrine Hydrochloride

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl, USP 120 mg

Purpos e

Nasal decongestant

Us es

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

allergies

temporarily relieves sinus congestion and pressure

Warnings

Do not use 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.

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur

symptoms do not improve within 7 days or occur with a fever

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 and over

take 1 tablet every 12 hours

do not take more than 2 tablets in 24

hours

children under 12

years

do not use this product in children under

12 years of age

Other information

store at 59° to 77° F in a dry place. Protect from light

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR

SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate,

titanium dioxide

Ques tions ?

call 1-800-406-7984

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL

33811

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

NDC 56062-204-21

NON-DROWSY

nasaldecongestant

PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

12-HOUR EXTENDED-RELEASE TABLETS, USP

LONG-ACTING NASAL DECONGESTANT

SINUS PRESSURE + CONGESTION

MAXIMUM STRENGTH

COATED CAPSULE-SHAPED TABLETS

120 mg EACH

ACTUAL SIZE

*Compare to the active ingredient

in Sudafed

12 Hour

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-20 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

CASTO R O IL (UNII: D5340 Y2I9 G)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

20 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:56 0 6 2-20 4-21 20 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

0 4/28 /20 0 6

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 77442

0 4/28 /20 0 6

Labeler -

Publix Super Markets Inc (006922009)

Registrant -

Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ohm Labo rato ries Inc.

18 476 9 0 29

ma nufa c ture (56 0 6 2-20 4)

Publix Super Markets Inc

Revised: 3/2019

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