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

  • NDC Code(s): 56062-204-21
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Pseudoephedrine HCl USP, 120 mg

    Close
  • PURPOSE

    Nasal decongestant

    Close
  • 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
    Close
  • 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.

    Close
  • 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
    Close
  • 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.
    Close
  • INACTIVE INGREDIENTS

    Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

    Close
  • PRINCIPAL DISPLAY PANEL

    Publix

    NON-DROWSY

    nasal decongestant

    PSEUDOEPHEDRINE HYDROCHLORIDE

    120 mg EXTENDED-RELEASE TABLETS, USP

    12 HOUR LONG-ACTING NASAL DECONGESTANT

    • nasal & sinus congestion due to colds & allergies
    • sinus pressure
    • maximum strength

    20 COATED CAPSULE-SHAPED TABLETS 120 mg EACH

    **Compare to Active Ingredient in Sudafed®12 Hour

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

    5089482/R1011

    This is the 20 count blister carton label for Publix Pseudoephedrine HCl 120 mg extended-release tablets, USP.

    Close
  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-204
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code 204
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-204-21 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077442 04/28/2006
    Labeler - Publix Super Markets Inc (006922009)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(56062-204)
    Close