Label: 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 March 14, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl, USP 120 mg

  • Purpose

    Nasal decongestant

  • Uses

    • 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 yearsdo 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

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    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

    20
    COATED CAPSULE-SHAPED TABLETS
    120 mg EACH

    ACTUAL SIZE

    *Compare to the active ingredient
    in Sudafed® 12 Hour

    PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    PSEUDOEPHEDRINE HYDROCHLORIDE 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 204
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-204-2120 in 1 BLISTER PACK; Type 0: Not a Combination Product04/28/2006
    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/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(56062-204)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!