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Pseudoephedrine Hydrochloride by Publix Super Markets Inc

Dosage form: tablet, film coated, extended release
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Publix Super Markets Inc
NDC Code: 56062-204

Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Pseudoephedrine HCl USP, 120 mg

PURPOSE

Nasal decongestant

USES

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • 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
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product
  • do not use more than directed

Stop use and ask a doctor if
  • symptoms do not get better within 7 days or occur with 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
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton

NDC 56062-204-21

NON-DROWSY
nasaldecongestant

PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
12-HOUR EXTENDED-RELEASE TABLETS, USP
LONG-ACTING NASAL DECONGESTANT

  • Nasal & sinus congestion due to colds & allergies
  • Sinus pressure
  • Maximum strength

20
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
SILICON DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
MAGNESIUM STEARATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code204
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-204-2120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744204/28/2006
Labeler - Publix Super Markets Inc (006922009)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(56062-204)

 
Publix Super Markets Inc

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Medically reviewed on Oct 22, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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